Status:
ACTIVE_NOT_RECRUITING
Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome
Lead Sponsor:
Sol-Gel Technologies, Ltd.
Conditions:
Gorlin Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of this clinical study is to find out how well Patidegib Gel 2% works in preventing new basal cell carcinomas (BCCs) developing on the face of adults with Gorlin syndrome, and how safe Patideg...
Detailed Description
This is a global, multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Gel 2%, applied topically twice daily to the face of adult subject...
Eligibility Criteria
Inclusion
- Key
- The subject must be at least 18 years old at the Screening Visit.
- The subject must be confirmed to have a PTCH1 mutation.
- The subject must have at least 10 BCCs on the face at Randomization (Baseline/Day 1).
- The subject must be willing to abstain from application of any non-study topical medication (prescription or over the counter) to their facial skin for the duration of the trial, except as prescribed by the investigator.
- Key
Exclusion
- The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study Investigational Product (IP).
- The subject is known to have hypersensitivity to any of the ingredients in the IP formulation.
- The subject has uncontrolled systemic disease.
- The subject has been treated for invasive cancer within the past 5 years excluding chronic lymphocytic leukemia Stage 0, non-melanoma skin cancer, successfully treated melanoma in situ and Stage I melanoma, Stage I cervical cancer, or ductal carcinoma in situ of the breast.
- Inefficacy of previous Hedgehog inhibitor therapy.
Key Trial Info
Start Date :
March 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06050122
Start Date
March 17 2024
End Date
August 1 2026
Last Update
October 14 2025
Active Locations (40)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, United States, 72758
2
Center for Dermatology Clinical Research
Fremont, California, United States, 94538
3
University of California Los Angeles (UCLA) - Center for Inflammatory Bowel Diseases - Westwood Location
Los Angeles, California, United States, 90024
4
The Dermatology Center of Newport
Newport Beach, California, United States, 92660