Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults with Gorlin Syndrome

Description

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 Patidegib Gel 2% is to use. People who take part will apply either Patidegib Gel 2% or a Vehicle Gel (with no active drug substance) to their face twice a day for a year (12 months). The number of new BCCs on the face will be compared between those who used Patidegib Gel 2% or Vehicle Gel after 12 months.

Conditions

Gorlin Syndrome

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Study Overview

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Study Details

Study overview

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 Patidegib Gel 2% is to use. People who take part will apply either Patidegib Gel 2% or a Vehicle Gel (with no active drug substance) to their face twice a day for a year (12 months). The number of new BCCs on the face will be compared between those who used Patidegib Gel 2% or Vehicle Gel after 12 months.

A Multicenter, Randomized, Double Blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Gel 2% for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects with Gorlin Syndrome

Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults with Gorlin Syndrome

Condition
Gorlin Syndrome
Intervention / Treatment

-

Contacts and Locations

Rogers

Northwest Arkansas Clinical Trials Center, Rogers, Arkansas, United States, 72758

Fremont

Center for Dermatology Clinical Research, Fremont, California, United States, 94538

Los Angeles

University of California Los Angeles (UCLA) - Center for Inflammatory Bowel Diseases - Westwood Location, Los Angeles, California, United States, 90024

Newport Beach

The Dermatology Center of Newport, Newport Beach, California, United States, 92660

Redwood City

Stanford University - Lucille Packard's Children's Hospital, Redwood City, California, United States, 94063

New Haven

Yale University, New Haven, Connecticut, United States, 06519

Tallahassee

Dermatology Associates of Tallahassee, Tallahassee, Florida, United States, 32308

Tampa

University of South Florida Health, Tampa, Florida, United States, 33612

Chicago

The University of Chicago Medicine, Chicago, Illinois, United States, 60637

Baltimore

The Johns Hopkins Hospital, Baltimore, Maryland, United States, 21287-0006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. The subject must be at least 18 years old at the Screening Visit.
  • 2. The subject must be confirmed to have a PTCH1 mutation.
  • 3. The subject must have at least 10 BCCs on the face at Randomization (Baseline/Day 1).
  • 4. 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.
  • 1. The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study Investigational Product (IP).
  • 2. The subject is known to have hypersensitivity to any of the ingredients in the IP formulation.
  • 3. The subject has uncontrolled systemic disease.
  • 4. 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.
  • 5. Inefficacy of previous Hedgehog inhibitor therapy.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sol-Gel Technologies, Ltd.,

Study Record Dates

2025-12