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CARE-1: A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts

Sponsor
Verrica Pharmaceuticals Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03981822
Collaborator
Instat Consulting, Inc. (Other), Paidion Research, Inc. (Industry), BioClinica, Inc. (Industry)
105
Enrollment
4
Locations
8
Arms
12.5
Actual Duration (Months)
26.3
Patients Per Site
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 2, double-blind, placebo-controlled study to determine the dose regimen, safety, tolerability, and efficacy of VP-102 in subjects with External Genital Warts (EGW). This study is divided into two parts (Part A and Part B). Increasing durations of skin exposure to study drug (VP-102 or placebo) will be evaluated in three treatment groups prior to progressing to enrollment in Part B. Part A & B will enroll a approximately 108 subjects completing 4 treatment applications every 21 days and continuing with follow-up assessments at Day 84, 112 and 147.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: VP-102 and applicator
  • Combination Product: Placebo
 Phase 2

Detailed Description

This study is to determine the Dose Regimen, Efficacy, Safety, and Tolerability of VP-102 in Subjects with External Genital Warts. It is divided into two parts (Part A and Part B). The aim of Part A is to determine the two best treatment regimens for evaluation of safety and efficacy in Part B.In Part A, Study drug (VP-102 or placebo) will be administered once every 21 days for up to four applications. Enrollment will begin in Group 1, then proceed into Group 2, and lastly into Group 3. A safety review will be conducted to determine whether enrollment can be initiated into the next Group. An additional blinded safety review will be performed after all six subjects in Group 3 have completed the 48-hour Visit, in order to support dose selection for Part B (Safety and Efficacy). Part B of the study will begin enrollment only after the Sponsor has selected the two dose regimens from Part A. The study will remain blinded until completion of both parts of the study.

In Part A, up to 18 subjects will be randomized to VP-102 or placebo treatment with three different regimens. When Part B is open an additional ~90 subjects will be enrolled and randomized to VP-102 or placebo with two treatment regimens. Two of the treatment arms will be VP-102 Regimen 1 and VP-102 Regimen 2. The other two treatment arms will be placebo (Placebo Regimen 1 and Placebo Regimen 2), with corresponding durations of skin exposure matching those selected for VP-102 Regimen 1 and Regimen 2. As an example, if the regimens selected from Part A are the 2-hour and 6-hour applications of VP-102, then VP-102 Regimen 1 would be VP-102 treatment for 2-hours and VP-102 Regimen 2 would be VP-102 treatment for 6-hours. Likewise, Placebo Regimen 1 would be placebo treatment for 2 hours and Placebo Regimen 2 would be placebo treatment for 6-hours. Randomization of the four treatment arms (VP-102 Regimen 1:VP-102 Regimen 2:Placebo Regimen 1:Placebo Regimen 2) will be 3:3:2:2. In both Regimen 1 and Regimen 2, study drug will be administered to EGW once every 21 days for up to four applications. Subjects will be asked to remove the study drug at the designated time selected from the dose regimen findings in Part A of the study. Treatment will continue with a minimum of every 21 days, until complete clearance or a maximum of four treatment sessions. Safety assessments including recording of local skin reactions are conducted at each treatment visit and at follow up visits Day 84, 112, and 147.

Study Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The aim of Part A is to determine the two best treatment regimens for evaluation of safety and efficacy in Part B. Increasing durations of skin exposure to study drug (VP-102 or placebo) will be evaluated in three treatment groups (n=6/group) that will enroll progressively. Part B of the study will begin enrollment only after the Sponsor has selected the two dose regimens in Part A, which will be called VP-102 Regimen 1 and Regimen 2.Approximately 90 subjects will be enrolled and randomized to one of four treatment arms (two treatment regimens, each with VP-102 and Placebo). Randomization will be stratified by sex so that neither gender exceeds ~60% of any treatment arm. Two of the treatment arms will be VP-102 Regimen 1 and VP-102 Regimen 2. The other two treatment arms will be placebo (Placebo Regimen 1 and Placebo Regimen 2), with corresponding durations of skin exposure matching those selected for VP-102 Regimen 1 and Regimen 2.The aim of Part A is to determine the two best treatment regimens for evaluation of safety and efficacy in Part B. Increasing durations of skin exposure to study drug (VP-102 or placebo) will be evaluated in three treatment groups (n=6/group) that will enroll progressively. Part B of the study will begin enrollment only after the Sponsor has selected the two dose regimens in Part A, which will be called VP-102 Regimen 1 and Regimen 2.Approximately 90 subjects will be enrolled and randomized to one of four treatment arms (two treatment regimens, each with VP-102 and Placebo). Randomization will be stratified by sex so that neither gender exceeds ~60% of any treatment arm. Two of the treatment arms will be VP-102 Regimen 1 and VP-102 Regimen 2. The other two treatment arms will be placebo (Placebo Regimen 1 and Placebo Regimen 2), with corresponding durations of skin exposure matching those selected for VP-102 Regimen 1 and Regimen 2.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-blind
Primary Purpose:
Treatment
Official Title:
A Phase 2, Double-Blind, Placebo-Controlled Study to Determine the Dose Regimen, Efficacy, Safety, and Tolerability of VP-102 in Subjects With External Genital Warts
Actual Study Start Date :
Jun 25, 2019
Actual Primary Completion Date :
May 21, 2020
Actual Study Completion Date :
Jul 8, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Part A: VP-102 2 hour-Active

For part A, VP-102 will be applied for 2 hours and removed. If selected as a dose regimen for Part B VP-102 will be applied for 2 hours and removed.In both parts, VP-102 is applied every 21 days for 4 treatments.

Combination Product: VP-102 and applicator
In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.
Other Names:
  • VP-102 (cantharidin) 0.7% w/v topical solution

    		•
    Active Comparator: Part A: VP-102 6-hour Active

    For part A, VP-102 will be applied for 6 hours and removed. If selected as a dose regimen for Part B VP-102 will be applied for 6 hours and removed. In both parts, VP-102 is applied every 21 days for 4 treatments.

    Combination Product: VP-102 and applicator
    In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.
    Other Names:
  • VP-102 (cantharidin) 0.7% w/v topical solution

    		•
    Active Comparator: Part A: VP-102 24-hour Active

    For part A, VP-102 will be applied for 24 hours and removed. If selected as a dose regimen for Part B, VP-102 will be applied for 24 hours and removed. In both parts, VP-102 is applied every 21 days for 4 treatments.

    Combination Product: VP-102 and applicator
    In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.
    Other Names:
  • VP-102 (cantharidin) 0.7% w/v topical solution

    		•
    Placebo Comparator: Part A: Placebo

    For part A, VP-102 will be applied for 2-,6- or 24- hours and removed. Placebo is applied every 21 days for 4 treatments.

    Combination Product: Placebo
    The placebo single-use applicator contains the same formulation as the VP-102 applicator but does not contain the active pharmaceutical ingredient cantharidin
    Active Comparator: Part B & A: VP-102 6 hour-Active

    Part B, VP-102 will be applied for 6 hours and removed. VP-102 is applied every 21 days for 4 treatments.

    Combination Product: VP-102 and applicator
    In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.
    Other Names:
  • VP-102 (cantharidin) 0.7% w/v topical solution

    		•
    Placebo Comparator: Part B & A: 6-hour-Placebo

    Part B, Placebo will be applied for 6 hours and removed. VP-102 is applied every 21 days for 4 treatments.

    Combination Product: Placebo
    The placebo single-use applicator contains the same formulation as the VP-102 applicator but does not contain the active pharmaceutical ingredient cantharidin
    Active Comparator: Part B & A: VP-102 24-hour Active

    For part A, VP-102 will be applied for 24 hours and removed. If 24 hours is selected as a dose regimen for Part B, VP-102 will be applied for 24 hours and removed. VP-102 is applied every 21 days for 4 treatments.

    Combination Product: VP-102 and applicator
    In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.
    Other Names:
  • VP-102 (cantharidin) 0.7% w/v topical solution

    		•
    Placebo Comparator: Part B & A: 24-hour-Placebo

    Part B, VP-Placebo will be applied for 24 hours and removed. VP-102 is applied every 21 days for 4 treatments.

    Combination Product: Placebo
    The placebo single-use applicator contains the same formulation as the VP-102 applicator but does not contain the active pharmaceutical ingredient cantharidin

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit. [Compares baseline wart count to Day 84, end of treatment.]

      Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the Study Day 84 EOT Visit.

    Secondary Outcome Measures

    1. Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) [Clearance compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.]

      Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

    2. Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) [Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.]

      Proportion of subjects exhibiting 90% clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

    3. Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) [Compared from baseline to each study visit, treatment 2, (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.]

      Proportion of subjects exhibiting 75% clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

    4. Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) [Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.]

      Change from baseline in the number of treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS). Number of warts present were recorded at each treatment visit as well as follow-up visits. For each post baseline treatment visit, the change in number of warts from baseline was calculated.

    5. Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) [Percent change from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.]

      Percent Change from Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

    Other Outcome Measures

    1. Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) [Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.]

      Proportion of subjects exhibiting reduction of ≥ 1 treatable wart from baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

    2. Proportion of Subjects Who Are Clear at the Study Day 84 (End of Treatment) Visit and Remain Clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study) [Complete clearance compared from Day 84 to follow-up days 112 and 147.]

      Proportion of subjects who are clear at all three study visits, Study Day 84 (End of Treatment) Visit and remain clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study).

    3. Change From Baseline in Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) [Baseline to Study Day 84, Follow-up Visits at Days 112 and 147 (EOS)]

      Change from baseline in total wart area (sum of individual warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

    4. Percent Change From Baseline in the Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) [Baseline to Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)]

      Percent Change from baseline in the total wart area (sum of individual warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • Be healthy, immunocompetent males or females ≥ 18 years of age

    • Present with ≥ 2 and ≤ 30 external genital and/or perianal warts in ≥ 1 of the following anatomic areas:

    • In both sexes: medial thigh (except inguinal fold); supra-pubic, perineal, and perianal areas

    • In men: over the glans penis (excluding urethral meatus), penis shaft, scrotum, and foreskin

    • In women: vulva (excluding labia minora and mucosal surfaces)

    • Have warts present for ≥ 4 weeks at the baseline visit

    • Have warts that are ≤ 8 mm in diameter each

    Key Exclusion Criteria:

    • Have a wart within the allowed treatment area > 8 mm in diameter or with an eroded or ulcerated surface, in the Investigator's opinion

    • Have an unclear diagnosis of condyloma

    • Have any wart types other than genital warts (e.g., common or plantar warts) that require treatment during the study period

    • Have active genital herpes eruption, or had active genital herpes lesions within 4 weeks before enrollment

    • Have a history of neoplasia or other HPV-associated malignancies within the last 5 years

    • Are systemically immunosuppressed

    • Are sexually active or may become sexually active and are unwilling to practice responsible birth control methods

    • Are pregnant or breastfeeding

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Indiana Clinical Trials Center,PC Plainfield Indiana United States 46168
    2 DelRicht Research Baton Rouge Louisiana United States 70816
    3 Clarkston Skin Research Clarkston Michigan United States 48346
    4 DelRicht Research Tulsa Oklahoma United States 74133

    Sponsors and Collaborators

    • Verrica Pharmaceuticals Inc.
    • Instat Consulting, Inc.
    • Paidion Research, Inc.
    • BioClinica, Inc.

    Investigators

    • Principal Investigator: Scott Guenthner, MD, The Indiana Clinical Trials Center

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Verrica Pharmaceuticals Inc.
    ClinicalTrials.gov Identifier:
    NCT03981822
    Other Study ID Numbers:
    • VP-102-104
    First Posted:
    Jun 11, 2019
    Last Update Posted:
    Sep 22, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Verrica Pharmaceuticals Inc.
    Human Papilloma Virus (HPV)
    Genital Warts
    Sexually Transmitted Disease (STD)
    Viral Disease
    Additional relevant MeSH terms:
    Communicable Diseases
    Infections
    Warts
    Sexually Transmitted Diseases
    Papillomavirus Infections
    Condylomata Acuminata
    Skin Diseases, Infectious
    Virus Diseases
    Sexually Transmitted Diseases, Viral
    Skin Diseases, Viral
    Skin Diseases
    Cantharidin

    Study Results

    Participant Flow

    Recruitment Details 2 groups from Part A were to be included in Part B based on Part A analysis.
    Pre-assignment Detail All subject numbers are based on ITT population. Participants in Part A 6-hour and 24-hour group were also included in Part B subject populations.
    Arm/Group Title Part A: VP-102 2-hour Part A: VP-102 6-hour Group Part A: VP-102 24-hour Group Part A: Placebo Part B: VP-102 6-hour Part B: Placebo 6-hour Part B: VP-102 24-hour Part B: Placebo 24-hour
    Arm/Group Description VP-102 and applicator: In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied. VP-102 and applicator: In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied. VP-102 and applicator: In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied. This includes 3 subjects that received placebo (1 each for the 2-hour; 6-hour and 24-hour) VP-102 and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied. Placebo and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied. VP-102 and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied. Placebo and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.
    Period Title: Overall Study
    STARTED 5 5 5 3 25 23 22 17
    COMPLETED 5 3 4 3 17 17 16 12
    NOT COMPLETED 0 2 1 0 8 6 6 5

    Baseline Characteristics

    Arm/Group Title Part A: VP-102 2-hour Part A: VP-102 6-hour Part A: VP-102 24-hour Part A: Placebo Part B: VP-102 6-hour Part B: 6-hour-Placebo Part B: VP-102 24-hour Part B: 24-hour-Placebo Total
    Arm/Group Description VP-102 will be applied for 2-hours and removed. VP-102 is applied every 21 days for 4 treatments. VP-102 will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments. VP-102 will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments. Placebo will be applied for 2-,6- or 12-hours and removed. Placebo is applied every 21 days for 4 treatments. VP-102 will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments. Placebo will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments. VP-102 will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments. Placebo will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments. Total of all reporting groups
    Overall Participants 5 5 5 3 25 23 22 17 105
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    34.40
    (9.915)
    43.00
    (8.246)
    33.80
    (5.263)
    32.00
    (3.606)
    38.12
    (10.138)
    35.87
    (7.973)
    34.45
    (7.526)
    33.88
    (6.470)
    35.85
    (8.260)
    Sex: Female, Male (Count of Participants)
    Female
    4
    80%
    3
    60%
    2
    40%
    0
    0%
    10
    40%
    10
    43.5%
    10
    45.5%
    7
    41.2%
    46
    43.8%
    Male
    1
    20%
    2
    40%
    3
    60%
    3
    100%
    15
    60%
    13
    56.5%
    12
    54.5%
    10
    58.8%
    59
    56.2%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    1
    20%
    0
    0%
    0
    0%
    0
    0%
    6
    24%
    1
    4.3%
    2
    9.1%
    5
    29.4%
    15
    14.3%
    Not Hispanic or Latino
    4
    80%
    5
    100%
    5
    100%
    3
    100%
    19
    76%
    22
    95.7%
    20
    90.9%
    12
    70.6%
    90
    85.7%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    4.3%
    0
    0%
    0
    0%
    1
    1%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    2
    40%
    0
    0%
    1
    20%
    0
    0%
    6
    24%
    8
    34.8%
    1
    4.5%
    6
    35.3%
    24
    22.9%
    White
    3
    60%
    5
    100%
    3
    60%
    3
    100%
    19
    76%
    12
    52.2%
    21
    95.5%
    11
    64.7%
    77
    73.3%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    1
    20%
    0
    0%
    0
    0%
    2
    8.7%
    0
    0%
    0
    0%
    3
    2.9%
    Region of Enrollment (participants) [Number]
    United States
    5
    100%
    5
    100%
    5
    100%
    3
    100%
    25
    100%
    23
    100%
    22
    100%
    17
    100%
    105
    100%
    Baseline number of treatable external genital warts (genital warts) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [genital warts]
    7
    (5.568)
    9.60
    (12.012)
    13.00
    (8.276)
    11.67
    (12.423)
    8.28
    (6.380)
    5.87
    (3.684)
    8.68
    (5.489)
    7.76
    (6.897)
    8.08
    (6.395)

    Outcome Measures

    1. Primary Outcome
    Title Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit.
    Description Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the Study Day 84 EOT Visit.
    Time Frame Compares baseline wart count to Day 84, end of treatment.

    Outcome Measure Data

    Analysis Population Description
    Part B and A: Intent-to-Treat Population. Part B summary is pooled with its respective treatments from Part A.
    Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour
    Arm/Group Description Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments.
    Measure Participants 30 24 27 18
    Yes
    11
    220%
    1
    20%
    9
    180%
    0
    0%
    No
    19
    380%
    23
    460%
    18
    360%
    18
    600%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0048
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0075
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    2. Secondary Outcome
    Title Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
    Description Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).
    Time Frame Clearance compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.

    Outcome Measure Data

    Analysis Population Description
    Part B and A pooled - ITT population
    Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour
    Arm/Group Description Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments.
    Measure Participants 30 24 27 18
    Treatment Visit 2: Yes, Complete Clearance
    1
    20%
    0
    0%
    4
    80%
    0
    0%
    Treatment Visit 3: Yes, Complete Clearance
    4
    80%
    0
    0%
    8
    160%
    2
    66.7%
    Treatment Visit 4: Yes, Complete Clearance
    6
    120%
    0
    0%
    7
    140%
    0
    0%
    Study Day 84 EOT: Yes, Complete Clearance
    11
    220%
    1
    20%
    9
    180%
    0
    0%
    F/U Visit Day 112: Yes, Complete Clearance
    9
    180%
    2
    40%
    8
    160%
    2
    66.7%
    F/U Visit Day 147: Yes, Complete Clearance
    6
    120%
    3
    60%
    8
    160%
    2
    66.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Treatment Visit 2 - Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3642
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0967
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0648
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1357
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0190
    Comments P-value is based on the CMH test stratified by gender. Part B summary is pooled with its respective treatments from
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0184
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Study Day 84 EOT Visit - Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0048
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Study Day 84 EOT Visit - Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0075
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Follow-up Visit Day 112 - Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0539
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Follow-up Visit Day 112 - Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1638
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Follow-up Visit Day 147 EOS - Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4766
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Follow-up Visit Day 147 EOS - Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1588
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    3. Secondary Outcome
    Title Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
    Description Proportion of subjects exhibiting 90% clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).
    Time Frame Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour
    Arm/Group Description Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments.
    Measure Participants 30 24 27 18
    Treatment Visit 2: Incidence of >=90% Clearance: YES
    1
    20%
    0
    0%
    4
    80%
    0
    0%
    Treatment Visit 3: Incidence of >=90% Clearance: YES
    5
    100%
    0
    0%
    8
    160%
    2
    66.7%
    Treatment Visit 4: Incidence of >=90% Clearance: YES
    7
    140%
    0
    0%
    7
    140%
    0
    0%
    Study Day 84 EOT: Incidence of >=90% Clearance: YES
    14
    280%
    2
    40%
    11
    220%
    0
    0%
    F/U Visit Day 112: Incidence of >=90% Clearance: YES
    11
    220%
    2
    40%
    9
    180%
    2
    66.7%
    F/U Visit Day 147: Incidence of >=90% Clearance: YES
    9
    180%
    3
    60%
    9
    180%
    2
    66.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Treatment Visit 2 Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3642
    Comments P-value is based on the CMH test stratified by gender. Part B summary is pooled with its respective treatments from Part A.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Treatment Visit 3 Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0356
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0118
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Study Day84 EOT Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0026
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Follow-up Visit Day 112 Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0174
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Follow-up Visit Day 147 EOS Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1311
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Treatment Visit 2 Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0967
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Treatment Visit 3 Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1357
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0184
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Study Day 84 EOT Visit Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0024
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Follow-up Visit Day 112 Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1034
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Follow-up Visit Day 147 EOS Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1029
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    4. Secondary Outcome
    Title Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
    Description Proportion of subjects exhibiting 75% clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).
    Time Frame Compared from baseline to each study visit, treatment 2, (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour
    Arm/Group Description Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments.
    Measure Participants 30 24 27 18
    Treatment Visit 2: Incidence of >=75% Clearance: YES
    5
    100%
    0
    0%
    6
    120%
    1
    33.3%
    Treatment Visit 3: Incidence of >=75% Clearance: YES
    8
    160%
    0
    0%
    14
    280%
    2
    66.7%
    Treatment Visit 4: Incidence of >=75% Clearance: YES
    11
    220%
    2
    40%
    12
    240%
    1
    33.3%
    Study Day 84 EOT: Incidence of >=75% Clearance: YES
    15
    300%
    2
    40%
    15
    300%
    2
    66.7%
    F/U Visit Day 112: Incidence of >=75% Clearance: YES
    13
    260%
    3
    60%
    13
    260%
    3
    100%
    F/U Visit Day 147: Incidence of >=75% Clearance: YES
    10
    200%
    4
    80%
    13
    260%
    2
    66.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0356
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1477
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0062
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0046
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0177
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0054
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Study Day 84 (EOT) visit: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0013
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Study Day 84 (EOT) Visit: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0034
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Follow-up visit day 112: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0156
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Follow-up visit day 112: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0367
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1746
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0123
    Comments
    Method Cochran-Mantel-Haenszel
    Comments P-value is based on the CMH test stratified by gender.
    5. Secondary Outcome
    Title Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
    Description Change from baseline in the number of treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS). Number of warts present were recorded at each treatment visit as well as follow-up visits. For each post baseline treatment visit, the change in number of warts from baseline was calculated.
    Time Frame Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.

    Outcome Measure Data

    Analysis Population Description
    ITT Populations
    Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour
    Arm/Group Description Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments.
    Measure Participants 30 24 27 18
    Treatment Visit 2
    -4.0
    (4.95)
    -0.3
    (1.11)
    -5.3
    (4.25)
    0.6
    (30.07)
    Treatment Visit 3
    -4.4
    (5.80)
    -1.1
    (3.69)
    -6.3
    (5.45)
    -0.5
    (5.01)
    Treatment Visit 4
    -5.2
    (4.72)
    -0.9
    (3.98)
    -7.1
    (5.09)
    0.5
    (5.17)
    Study Day 84 EOT Visit
    -6.1
    (5.24)
    -1.1
    (4.92)
    -7.4
    (6.37)
    0.1
    (5.12)
    Follow up Day 112
    -5.3
    (5.21)
    -1.1
    (5.33)
    -8.1
    (5.54)
    -0.3
    (4.39)
    Follow-up Visit Day 147 EOS
    -5.0
    (7.63)
    -1.2
    (5.49)
    -7.9
    (5.46)
    -0.1
    (4.66)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0021
    Comments Analysis is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, Tx by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -3.96
    Confidence Interval (2-Sided) 95%
    -5.41 to -1.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0150
    Comments
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -4.72
    Confidence Interval (2-Sided) 95%
    -5.95 to -0.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments Analysis is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -5.31
    Confidence Interval (2-Sided) 95%
    -6.54 to -1.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Study Day 84 EOT Visit: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments P-value is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -6.50
    Confidence Interval (2-Sided) 95%
    -8.25 to -2.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Follow-up day 112: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0012
    Comments P-value is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -6.15
    Confidence Interval (2-Sided) 95%
    -7.50 to -1.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0349
    Comments P-value is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -5.02
    Confidence Interval (2-Sided) 95%
    -6.78 to -0.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Treatment visit 2: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments P-value is based on MMRM mode
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -4.76
    Confidence Interval (2-Sided) 95%
    -7.47 to -2.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Treatment Visit 3: Degrees of freedom associated with the error term were computed using Kenward-Rogers method.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments Analysis is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -6.00
    Confidence Interval (2-Sided) 95%
    -8.37 to -2.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Treatment visit 4: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Analysis based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -6.64
    Confidence Interval (2-Sided) 95%
    -9.65 to -4.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments Analysis is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -6.49
    Confidence Interval (2-Sided) 95%
    -9.67 to -2.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Follow-up day 112: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Analysis based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -6.96
    Confidence Interval (2-Sided) 95%
    -9.89 to -3.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Follow up day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments Analysis based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -6.99
    Confidence Interval (2-Sided) 95%
    -10.20 to -2.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
    Description Percent Change from Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).
    Time Frame Percent change from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour
    Arm/Group Description Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments.
    Measure Participants 30 24 27 18
    Treatment Visit 2
    -41.4
    (32.38)
    -6.2
    (13.14)
    -58.5
    (26.69)
    -2.6
    (30.07)
    Treatment Visit 3
    -49.0
    (37.18)
    -8.9
    (44.46)
    -69.3
    (34.03)
    -17.8
    (49.79)
    Treatment Visit 4
    -65.8
    (30.69)
    -5.1
    (66.26)
    -77.3
    (26.87)
    0.6
    (41.94)
    Study Day 84 End of Treatment Visit
    -79.7
    (34.27)
    -1.6
    (78.34)
    -77.1
    (38.66)
    -5.5
    (47.98)
    Follow up Day 112
    -68.2
    (43.20)
    1.9
    (91.11)
    -79.2
    (28.36)
    -14.2
    (49.60)
    Follow up Visit Day 147 End of Study
    -42.5
    (111.83)
    -6.0
    (86.56)
    -79.6
    (25.01)
    -12.9
    (50.49)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments P-value is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -41.47
    Confidence Interval (2-Sided) 95%
    -51.31 to -20.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments P-value is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -50.95
    Confidence Interval (2-Sided) 95%
    -66.18 to -19.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments P-value is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -66.21
    Confidence Interval (2-Sided) 95%
    -88.15 to -35.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Study Day 84 End of Treatment Visit: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments P-value is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -79.37
    Confidence Interval (2-Sided) 95%
    -111.44 to -49.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Follow up Day 112: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments P-value is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -69.79
    Confidence Interval (2-Sided) 95%
    -103.17 to -35.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Follow up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1033
    Comments P-value is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -41.22
    Confidence Interval (2-Sided) 95%
    -90.61 to 8.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments P-value is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -58.43
    Confidence Interval (2-Sided) 95%
    -73.26 to -39.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments P-value is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -69.86
    Confidence Interval (2-Sided) 95%
    -81.61 to -28.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments P-value is based on MMRM model with gender, treatment, visit, treatment by visit interaction, and baseline wart count as factors.
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -76.55
    Confidence Interval (2-Sided) 95%
    -107.19 to -45.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Study Day 84 End of Treatment Visit: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0003
    Comments P-value is based on MMRM model with gender, treatment, visit, treatment by visit interaction, and baseline wart count as factors.
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -74.29
    Confidence Interval (2-Sided) 95%
    -102.96 to -31.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments P-value is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -77.10
    Confidence Interval (2-Sided) 95%
    -110.32 to -32.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0178
    Comments P-value is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -77.52
    Confidence Interval (2-Sided) 95%
    -120.82 to -11.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Other Pre-specified Outcome
    Title Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
    Description Proportion of subjects exhibiting reduction of ≥ 1 treatable wart from baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).
    Time Frame Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.

    Outcome Measure Data

    Analysis Population Description
    ITT population
    Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour
    Arm/Group Description Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments.
    Measure Participants 30 24 27 18
    Yes - at least 1 wart reduction from Baseline
    22
    440%
    6
    120%
    23
    460%
    6
    200%
    No
    8
    160%
    18
    360%
    4
    80%
    12
    400%
    Yes - at least 1 wart reduction from Baseline
    20
    400%
    10
    200%
    21
    420%
    7
    233.3%
    No
    10
    200%
    14
    280%
    6
    120%
    11
    366.7%
    Yes - at least 1 wart reduction from Baseline
    23
    460%
    10
    200%
    17
    340%
    4
    133.3%
    No
    7
    140%
    14
    280%
    10
    200%
    14
    466.7%
    Yes - at least 1 wart reduction from Baseline
    19
    380%
    9
    180%
    18
    360%
    4
    133.3%
    No
    11
    220%
    15
    300%
    9
    180%
    14
    466.7%
    Yes - at least 1 wart reduction from Baseline
    17
    340%
    10
    200%
    18
    360%
    5
    166.7%
    No
    13
    260%
    14
    280%
    9
    180%
    13
    433.3%
    Yes - at least 1 wart reduction from Baseline
    13
    260%
    8
    160%
    19
    380%
    5
    166.7%
    No
    17
    340%
    16
    320%
    8
    160%
    13
    433.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0004
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0698
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0100
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0101
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0077
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Study Day 84 EOT Visit: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0640
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Study Day 84 EOT: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0045
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2840
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0132
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Follow-up Visit Day 147 EOS: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4668
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Follow-up Visit Day 147 EOS: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0064
    Comments P-value is based on the CMH test stratified by gender.
    Method Cochran-Mantel-Haenszel
    Comments
    8. Other Pre-specified Outcome
    Title Proportion of Subjects Who Are Clear at the Study Day 84 (End of Treatment) Visit and Remain Clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study)
    Description Proportion of subjects who are clear at all three study visits, Study Day 84 (End of Treatment) Visit and remain clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study).
    Time Frame Complete clearance compared from Day 84 to follow-up days 112 and 147.

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour
    Arm/Group Description Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments.
    Measure Participants 30 24 27 18
    Yes
    5
    100%
    0
    0%
    7
    140%
    0
    0%
    No
    25
    500%
    24
    480%
    20
    400%
    18
    600%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0364
    Comments
    Method Mantel Haenszel
    Comments Stratified by gender
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0215
    Comments
    Method Cochran-Mantel-Haenszel
    Comments Stratified by gender
    9. Other Pre-specified Outcome
    Title Change From Baseline in Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
    Description Change from baseline in total wart area (sum of individual warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).
    Time Frame Baseline to Study Day 84, Follow-up Visits at Days 112 and 147 (EOS)

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour
    Arm/Group Description Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments.
    Measure Participants 30 24 27 18
    Study Day 84 (EOT)
    -52.60
    (67.067)
    -23.64
    (59.722)
    -72.87
    (91.659)
    1.60
    (33.796)
    Follow-up Day 112
    -79.43
    (99.679)
    -20.35
    (53.289)
    -82.79
    (71.750)
    1.40
    (39.963)
    Follow-up Visit Day 147 (EOS)
    -59.28
    (100.988)
    -6.02
    (36.929)
    -68.78
    (68.710)
    2.21
    (45.035)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Study Day 84 (EOT: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1222
    Comments Analysis is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -59.63
    Confidence Interval (2-Sided) 95%
    -76.10 to 9.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Study Day 112 (EOT: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0403
    Comments Analysis based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value - 69.51
    Confidence Interval (2-Sided) 95%
    -81.30 to -1.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Follow-up Visit Day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0863
    Comments Analysis is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -58.88
    Confidence Interval (2-Sided) 95%
    -77.79 to 5.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0428
    Comments Analysis is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -62.13
    Confidence Interval (2-Sided) 95%
    -100.76 to -1.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0084
    Comments Analysis is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -71.93
    Confidence Interval (2-Sided) 95%
    -110.46 to -17.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Follow-up Visit Day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0273
    Comments Analysis is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -63.11
    Confidence Interval (2-Sided) 95%
    -103.08 to -6.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Other Pre-specified Outcome
    Title Percent Change From Baseline in the Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
    Description Percent Change from baseline in the total wart area (sum of individual warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).
    Time Frame Baseline to Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)

    Outcome Measure Data

    Analysis Population Description
    ITT Population
    Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour
    Arm/Group Description Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments.
    Measure Participants 30 24 27 18
    Study Day 84 (EOT)
    -46.0
    (52.77)
    -22.3
    (57.92)
    -64.2
    (55.78)
    -7.3
    (93.42)
    Follow-up Day 112
    -48.2
    (54.67)
    -21.5
    (64.54)
    -76.4
    (12.33)
    13.8
    (129.61)
    Follow-up Day 147 (EOS)
    -45.8
    (71.37)
    -11.7
    (52.52)
    -69.3
    (16.44)
    19.9
    (138.49)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments Analysis is based on MMRM model
    Statistical Test of Hypothesis p-Value 0.3083
    Comments
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value - 44.65
    Confidence Interval (2-Sided) 95%
    -69.96 to 22.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1686
    Comments Analysis is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value - 55.80
    Confidence Interval (2-Sided) 95%
    -86.93 to 15.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
    Comments Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2384
    Comments Analysis is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value - 38.06
    Confidence Interval (2-Sided) 95%
    -87.04 to 22.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0603
    Comments Analysis is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value - 61.96
    Confidence Interval (2-Sided) 95%
    -103.37 to 2.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0109
    Comments Analysis is based on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value - 74.87
    Confidence Interval (2-Sided) 95%
    -138.71 to -18.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
    Comments Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0467
    Comments Analysis is base on MMRM model
    Method Mixed Models Analysis
    Comments MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors. An unstructured covariance model was used.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value - 66.62
    Confidence Interval (2-Sided) 95%
    -127.64 to -0.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame Adverse Events (AEs) were collected following the first application of study drug through Study Day 147.
    Adverse Event Reporting Description TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
    Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour Part A: VP-102 2-hour Part A: Placebo 2-hour
    Arm/Group Description Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data summarized for VP-102 2-hour group. Data summarized for VP-102 2-hour group..
    All Cause Mortality
    Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour Part A: VP-102 2-hour Part A: Placebo 2-hour
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/29 (0%) 0/22 (0%) 0/28 (0%) 0/20 (0%) 0/5 (0%) 0/1 (0%)
    Serious Adverse Events
    Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour Part A: VP-102 2-hour Part A: Placebo 2-hour
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/29 (3.4%) 1/22 (4.5%) 0/28 (0%) 1/20 (5%) 0/5 (0%) 0/1 (0%)
    Infections and infestations
    Pneumonia 0/29 (0%) 0/22 (0%) 0/28 (0%) 1/20 (5%) 0/5 (0%) 0/1 (0%)
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain 1/29 (3.4%) 0/22 (0%) 0/28 (0%) 0/20 (0%) 0/5 (0%) 0/1 (0%)
    Psychiatric disorders
    Bipolar disorder 0/29 (0%) 1/22 (4.5%) 0/28 (0%) 0/20 (0%) 0/5 (0%) 0/1 (0%)
    Other (Not Including Serious) Adverse Events
    Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour Part A: VP-102 2-hour Part A: Placebo 2-hour
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 29/29 (100%) 15/22 (68.2%) 28/28 (100%) 9/20 (45%) 5/5 (100%) 0/1 (0%)
    Gastrointestinal disorders
    Nausea 0/29 (0%) 1/22 (4.5%) 0/28 (0%) 1/20 (5%) 0/5 (0%) 0/1 (0%)
    Vomiting 0/29 (0%) 0/22 (0%) 0/28 (0%) 0/20 (0%) 1/5 (20%) 0/1 (0%)
    Gastritis 0/29 (0%) 0/22 (0%) 0/28 (0%) 0/20 (0%) 1/5 (20%) 0/1 (0%)
    General disorders
    Application site vesicles 25/29 (86.2%) 0/22 (0%) 26/28 (92.9%) 1/20 (5%) 4/5 (80%) 0/1 (0%)
    Application site pain 20/29 (69%) 3/22 (13.6%) 19/28 (67.9%) 4/20 (20%) 4/5 (80%) 0/1 (0%)
    Application site erythema 14/29 (48.3%) 3/22 (13.6%) 19/28 (67.9%) 1/20 (5%) 2/5 (40%) 0/1 (0%)
    Application site pruritus 14/29 (48.3%) 5/22 (22.7%) 10/28 (35.7%) 1/20 (5%) 1/5 (20%) 0/1 (0%)
    Application site scab 13/29 (44.8%) 1/22 (4.5%) 14/28 (50%) 0/20 (0%) 1/5 (20%) 0/1 (0%)
    Application site discolouration 7/29 (24.1%) 4/22 (18.2%) 6/28 (21.4%) 0/20 (0%) 4/5 (80%) 0/1 (0%)
    Application site dryness 7/29 (24.1%) 2/22 (9.1%) 6/28 (21.4%) 1/20 (5%) 1/5 (20%) 0/1 (0%)
    Application site erosion 6/29 (20.7%) 0/22 (0%) 7/28 (25%) 0/20 (0%) 4/5 (80%) 0/1 (0%)
    Application site oedema 3/29 (10.3%) 1/22 (4.5%) 7/28 (25%) 1/20 (5%) 3/5 (60%) 0/1 (0%)
    Application site exfoliation 3/29 (10.3%) 2/22 (9.1%) 5/28 (17.9%) 0/20 (0%) 1/5 (20%) 0/1 (0%)
    Infections and infestations
    Sinusitis 3/29 (10.3%) 1/22 (4.5%) 0/28 (0%) 0/20 (0%) 0/5 (0%) 0/1 (0%)
    Tooth abscess 0/29 (0%) 0/22 (0%) 0/28 (0%) 1/20 (5%) 0/5 (0%) 0/1 (0%)
    Abscess limb 0/29 (0%) 0/22 (0%) 0/28 (0%) 0/20 (0%) 1/5 (20%) 0/1 (0%)
    Nasopharyngitis 0/29 (0%) 1/22 (4.5%) 0/28 (0%) 0/20 (0%) 1/5 (20%) 0/1 (0%)
    Vulvovaginal mycotic infection 0/29 (0%) 0/22 (0%) 0/28 (0%) 0/20 (0%) 1/5 (20%) 0/1 (0%)
    Injury, poisoning and procedural complications
    Toxicity to various agents 0/29 (0%) 0/22 (0%) 0/28 (0%) 1/20 (5%) 0/5 (0%) 0/1 (0%)
    Musculoskeletal and connective tissue disorders
    Arthritis 0/29 (0%) 0/22 (0%) 0/28 (0%) 1/20 (5%) 0/5 (0%) 0/1 (0%)
    Nervous system disorders
    Headache 0/29 (0%) 0/22 (0%) 0/28 (0%) 0/20 (0%) 1/5 (20%) 0/1 (0%)
    Psychiatric disorders
    Anxiety 0/29 (0%) 1/22 (4.5%) 0/28 (0%) 1/20 (5%) 0/5 (0%) 0/1 (0%)
    Depression 0/29 (0%) 1/22 (4.5%) 0/28 (0%) 1/20 (5%) 0/5 (0%) 0/1 (0%)
    Insomnia 0/29 (0%) 1/22 (4.5%) 0/28 (0%) 1/20 (5%) 0/5 (0%) 0/1 (0%)
    Major Depression 0/29 (0%) 0/22 (0%) 0/28 (0%) 0/20 (0%) 1/5 (20%) 0/1 (0%)
    Suicide attempt 0/29 (0%) 0/22 (0%) 0/28 (0%) 0/20 (0%) 1/5 (20%) 0/1 (0%)
    Reproductive system and breast disorders
    Vulvovaginal pruritus 0/29 (0%) 0/22 (0%) 0/28 (0%) 0/20 (0%) 1/5 (20%) 0/1 (0%)
    Surgical and medical procedures
    Umbilical hernia repair 0/29 (0%) 0/22 (0%) 0/28 (0%) 0/20 (0%) 1/5 (20%) 0/1 (0%)

    Limitations/Caveats

    Due to logistical and/or scheduling difficulties related to the SARS-CoV-2 (coronavirus-19; COVID-19) pandemic during the course of the study, six subjects discontinued due to COVID-19 related reasons.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    PI is bound to terms and conditions of a Sponsored Clinical Trial Agreement which has strict confidentiality obligations running to Sponsor and broad provisions restricting PI's rights to publish or present any data or Study Results without Sponsor's express review consent and review.

    Results Point of Contact

    Name/Title Susan Cutler, VP, Medical Affairs
    Organization Verrica Pharmaceuticals
    Phone 484-773-0898
    Email scutler@verrica.com
    Responsible Party:
    Verrica Pharmaceuticals Inc.
    ClinicalTrials.gov Identifier:
    NCT03981822
    Other Study ID Numbers:
    • VP-102-104
    First Posted:
    Jun 11, 2019
    Last Update Posted:
    Sep 22, 2021
    Last Verified:
    Aug 1, 2021