An Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas in Patients With Non-Gorlin High Frequency BCC

Sponsor
PellePharm, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT04155190
Collaborator
(none)
47
14
2
16.1
3.4
0.2

Study Details

Study Description

Brief Summary

This is a multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult participants with non-Gorlin HF-BCC (high-frequency basal cell carcinoma). Participants will be randomized (1:1) to receive either Patidegib Topical Gel, 2%, or Vehicle for 9 months. Randomization will be stratified by gender. The primary endpoint is the number of nSEB (surgically eligible basal cell carcinoma) that develop on the face over the 9 month period. The primary end point will be assessed by imaging and tracking of BCCs consistently throughout the study in order to identify nSEBs.

Condition or Disease Intervention/Treatment Phase
  • Drug: Patidegib Topical Gel, 2%
  • Drug: Patidegib Topical Gel, Vehicle
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomized (1:1) to receive either Patidegib Topical Gel, 2%, or Vehicle for 9 months. Randomization will be stratified by gender.Participants will be randomized (1:1) to receive either Patidegib Topical Gel, 2%, or Vehicle for 9 months. Randomization will be stratified by gender.
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
As a double-blinded study, the Investigators, the site staff, PellePharm, and the Clinical Monitor(s) will be blinded to the treatment assigned to individual subjects. Delegated staff members at the study site will dispense the investigational product (IP) and will collect and weigh all used and unused IP tubes.
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double Blind, Vehicle-controlled, Phase 2 Efficacy and Safety Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Patients With Non-Gorlin High Frequency BCC
Actual Study Start Date :
Dec 20, 2019
Actual Primary Completion Date :
Apr 23, 2021
Actual Study Completion Date :
Apr 23, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patidegib Topical Gel, 2%

Participants will be randomized (1:1) to receive Patidegib Topical Gel, 2% for 9 months

Drug: Patidegib Topical Gel, 2%
Patidegib Topical Gel, 2%
Other Names:
  • IP
  • Active Comparator: Patidegib Topical Gel, Vehicle

    Participants will be randomized (1:1) to receive Patidegib Topical Gel, Vehicle for 9 months

    Drug: Patidegib Topical Gel, Vehicle
    Patidegib Topical Gel, Vehicle
    Other Names:
  • IP, Vehicle
  • Outcome Measures

    Primary Outcome Measures

    1. Number of new surgically eligible BCCs (nSEBs) [Baseline through Month 9]

    Secondary Outcome Measures

    1. Number of treatment emergent adverse events assessed with means and standard errors or proportions [Baseline through Month 9]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. The subject must have had at least 10 (with at least 3 on the face) clinically typical BCCs present within 24 months prior to Screening and Randomization (Baseline/Day 1). Additionally, the subject must have at least 2 BCCs with longest diameter <5 mm present on the face prior to Screening and Randomization (Baseline/Day 1).

    2. The subject must be willing to abstain from application of a non-study topical medication (prescription or over the counter) to facial skin for the duration of the trial except as prescribed by the Investigator.

    Exclusion Criteria:
    1. The subject has been previously diagnosed with Gorlin syndrome

    2. On medical history, family history or clinical examination there is a suspicion that the patient has Gorlin syndrome.

    3. Patients with a family history of medulloblastoma

    4. The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP.

    5. The subject has uncontrolled systemic disease.

    6. The subject has been treated for invasive cancer within the past 5 years excluding non-melanoma skin cancer, Stage I cervical cancer, ductal carcinoma in situ of the breast, or chronic lymphocytic leukemia (CLL) Stage 0.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Axiom Research, LLC Apple Valley California United States 92307
    2 Axiom Research, LLC Colton California United States 92324
    3 Center for Dermatology Clinical Research, Inc. Fremont California United States 94538
    4 Dermatology Research Associates Los Angeles California United States 90045
    5 The Dermatology Center of Newport Newport Beach California United States 92660
    6 Palm Beach Dermatology Research Delray Beach Florida United States 33484
    7 Leavitt Medical Associates of Florida Ormond Beach Florida United States 32174
    8 PellePharm Investigative Site Saint Augustine Florida United States 32080
    9 The Indiana Clinical Trials Center Plainfield Indiana United States 46168
    10 Grekin Skin Institute Warren Michigan United States 48088
    11 PellePharm Investigative Site Henderson Nevada United States 89052
    12 Skin Laser and Surgery Specialists of NY&NJ Hackensack New Jersey United States 07601
    13 Duke University Medical Center Durham North Carolina United States 27710
    14 University of Utah Murray Utah United States 84107

    Sponsors and Collaborators

    • PellePharm, Inc.

    Investigators

    • Study Director: VP, Clinical Operations, PellePharm, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    PellePharm, Inc.
    ClinicalTrials.gov Identifier:
    NCT04155190
    Other Study ID Numbers:
    • Pelle-926-203
    First Posted:
    Nov 7, 2019
    Last Update Posted:
    May 27, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by PellePharm, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 27, 2021