ACTIVE_NOT_RECRUITING

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

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Conditions

Gorlin Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-03-17
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06050122

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. The subject must be at least 18 years old at the Screening Visit.
  2. 2. The subject must be confirmed to have a PTCH1 mutation.
  3. 3. The subject must have at least 10 BCCs on the face at Randomization (Baseline/Day 1).
  4. 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. 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. 2. The subject is known to have hypersensitivity to any of the ingredients in the IP formulation.
  3. 3. The subject has uncontrolled systemic disease.
  4. 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. 5. Inefficacy of previous Hedgehog inhibitor therapy.

Contacts and Locations

Study Locations (Sites)

Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, 72758
United States
Center for Dermatology Clinical Research
Fremont, California, 94538
United States
University of California Los Angeles (UCLA) - Center for Inflammatory Bowel Diseases - Westwood Location
Los Angeles, California, 90024
United States
The Dermatology Center of Newport
Newport Beach, California, 92660
United States
Stanford University - Lucille Packard's Children's Hospital
Redwood City, California, 94063
United States
Yale University
New Haven, Connecticut, 06519
United States
Dermatology Associates of Tallahassee
Tallahassee, Florida, 32308
United States
University of South Florida Health
Tampa, Florida, 33612
United States
The University of Chicago Medicine
Chicago, Illinois, 60637
United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287-0006
United States
University of Michigan Health - Michigan Medicine - University Hospital
Ann Arbor, Michigan, 48109
United States
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
United States
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
United States
Schweiger Dermatology P.C.
Verona, New Jersey, 07044
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Duke University Health System
Durham, North Carolina, 27710
United States
Apex Clinical Research Center
Canton, Ohio, 44718
United States
Cleveland Clinic - Main Campus
Cleveland, Ohio, 44195
United States
Apex Clinical Research Center
Mayfield Heights, Ohio, 44124
United States
SSM Health Dermatology
Oklahoma City, Oklahoma, 73102
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
North Texas Center for Clinical Research
Frisco, Texas, 75034
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Sol-Gel Technologies, Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-17
Study Completion Date2026-08

Study Record Updates

Study Start Date2024-03-17
Study Completion Date2026-08

Terms related to this study

Additional Relevant MeSH Terms

  • Gorlin Syndrome