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P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne

Sponsor
Novan, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02667444
Collaborator
Chiltern International Inc. (Industry)
1,330
Enrollment
55
Locations
2
Arms
9.7
Actual Duration (Months)
24.2
Patients Per Site
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.

Condition or Disease Intervention/Treatment Phase
  • Drug: SB204 4%
  • Drug: Vehicle Gel
 Phase 3

Detailed Description

This is a double-blind, placebo controlled study in subjects with moderate to severe acne. Subjects who satisfy the entry criteria will be randomized to SB204 4% QD or Vehicle Gel QD in a 1:1 ratio. Efficacy assessments will include Investigator Global Assessments (IGA) and inflammatory and non-inflammatory lesion counts. Subjects will return for post-Baseline evaluation at Weeks 2, 4, 8, and 12/Early Termination (ET).

Study Design

Study Type:
Interventional
Actual Enrollment :
1330 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of Once Daily SB204 and Vehicle Gel in the Treatment of Acne Vulgaris
Actual Study Start Date :
Feb 19, 2016
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 9, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: SB204 4%

SB204 4% topically once daily

Drug: SB204 4%
Applied topically once daily
Other Names:
  • NVN1000

    		•
    Placebo Comparator: Vehicle Gel

    Vehicle Gel topically once daily

    Drug: Vehicle Gel
    Applied topically one daily
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Absolute change in inflammatory lesion counts [From baseline to week 12]

      change in inflammatory lesion counts

    2. Absolute change in non-inflammatory lesion counts [From baseline to week 12]

      change in non-inflammatory lesion counts

    3. Proportion of subjects with Investigator Global Assessment (IGA) Success defined as Clear/Almost Clear and at least 2 grade improvement from Baseline [Week 12]

      IGA success at Week 12

    Secondary Outcome Measures

    1. Per cent change in inflammatory lesion count [Week 12]

      The per change from baseline in inflammatory lesion count

    2. Per cent change in non-inflammatory lesion count [Week 12]

      The per change from baseline in non-inflammatory lesion count

    3. Time to reduction in inflammatory lesion count [Week 12]

      Time to reduction in inflammatory lesion count

    4. Time to improvement in IGA [Week 12]

      Time to improvement in IGA

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    9 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Moderate to severe acne

    • Minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones) on the face

    • Minimum of 20 and no more than 40 inflammatory lesions (papules and pustules)

    Exclusion Criteria:

    • Women of child-bearing potential who are pregnant, nursing, considering becoming pregnant

    • Any dermatologic condition that could interfere with clinical evaluations including severe, recalcitrant cystic acne

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CIL #214 Birmingham Alabama United States 35233
    2 CIL #218 Mobile Alabama United States 36608
    3 CIL #189 Phoenix Arizona United States 85018
    4 CIL #139 Cerritos California United States 90703
    5 CIL #216 Chula Vista California United States 91911
    6 CIL #181 Encino California United States 91436
    7 CIL #174 Huntington Beach California United States 92647
    8 CIL #213 La Mesa California United States 91942
    9 CIL #190 Sacramento California United States 95821
    10 CIL #111 San Diego California United States 92123
    11 CIL #195 Santa Ana California United States 92705
    12 CIL #119 Santa Monica California United States 90404
    13 CIL #158 Bradenton Florida United States 34201
    14 CIL #208 Hialeah Florida United States 33012
    15 CIL #170 Miami Lakes Florida United States 33016
    16 CIL #204 Miami Springs Florida United States 33166
    17 CIL #142 Miami Florida United States 33157
    18 CIL #185 Ormond Beach Florida United States 32174
    19 CIL #110 Pinellas Park Florida United States 33781
    20 CIL #176 Saint Petersburg Florida United States 33716
    21 CIL #227 Sanford Florida United States 32771
    22 CIL #152 Tampa Florida United States 33607
    23 CIL #144 Tampa Florida United States 33634
    24 CIL #116 Newnan Georgia United States 30263
    25 CIL #143 Savannah Georgia United States 31406
    26 CIL #175 New Albany Indiana United States 47150
    27 CIL #191 Overland Park Kansas United States 66215
    28 CIL #228 Louisville Kentucky United States 40217
    29 CIL #194 Richmond Kentucky United States 40475
    30 CIL #219 Monroe Louisiana United States 71203
    31 CIL #145 Boston Massachusetts United States 02114
    32 CIL #155 Bay City Michigan United States 48706
    33 CIL #220 Saint Louis Missouri United States 63141
    34 CIL #148 Norfolk Nebraska United States 68701
    35 CIL #206 Omaha Nebraska United States 68144
    36 CIL #202 Morristown New Jersey United States 07962
    37 CIL #197 New York New York United States 10024
    38 CIL #196 Charlotte North Carolina United States 28277
    39 CIL #192 Raleigh North Carolina United States 27612
    40 CIL #221 Salisbury North Carolina United States 28144
    41 CIL #169 Cincinnati Ohio United States 45246
    42 CIL #237 Gresham Oregon United States 97030
    43 CIL #137 Broomall Pennsylvania United States 19008
    44 CIL #147 Hershey Pennsylvania United States 17033
    45 CIL #178 Philadelphia Pennsylvania United States 19103
    46 CIL #160 Austin Texas United States 78735
    47 CIL #183 Austin Texas United States 78759
    48 CIL #184 Bryan Texas United States 77802
    49 CIL #163 Channelview Texas United States 77530
    50 CIL #165 Dallas Texas United States 75230
    51 CIL #167 Houston Texas United States 77030
    52 CIL #223 Plano Texas United States 75024
    53 CIL #159 San Antonio Texas United States 78229
    54 CIL #105 Lynchburg Virginia United States 24501
    55 CIL #231 Norfolk Virginia United States 23507

    Sponsors and Collaborators

    • Novan, Inc.
    • Chiltern International Inc.

    Investigators

    • Study Chair: Joyce Rico, MD, Novan, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novan, Inc.
    ClinicalTrials.gov Identifier:
    NCT02667444
    Other Study ID Numbers:
    • NI-AC302
    First Posted:
    Jan 29, 2016
    Last Update Posted:
    May 15, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Acne Vulgaris

    Study Results

    No Results Posted as of May 15, 2019