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Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome
Sponsor: Sol-Gel Technologies, Ltd.
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 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2024-03-17
Completion Date
2026-08
Last Updated
2025-10-14
Healthy Volunteers
No
Conditions
Interventions
Patidegib Topical Gel
Patidegib Gel 2% is a smooth, clear, colorless-to-yellow, viscous, hydro-alcoholic gel for topical administration.
Patidegib Topical Gel with no active patidegib
Vehicle Gel consists of the excipients of Patidegib Gel with no active patidegib. It is a smooth viscous gel for topical administration.
Locations (40)
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, United States
Center for Dermatology Clinical Research
Fremont, California, United States
University of California Los Angeles (UCLA) - Center for Inflammatory Bowel Diseases - Westwood Location
Los Angeles, California, United States
The Dermatology Center of Newport
Newport Beach, California, United States
Stanford University - Lucille Packard's Children's Hospital
Redwood City, California, United States
Yale University
New Haven, Connecticut, United States
Dermatology Associates of Tallahassee
Tallahassee, Florida, United States
University of South Florida Health
Tampa, Florida, United States
The University of Chicago Medicine
Chicago, Illinois, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Michigan Health - Michigan Medicine - University Hospital
Ann Arbor, Michigan, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Schweiger Dermatology P.C.
Verona, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University Health System
Durham, North Carolina, United States
Apex Clinical Research Center
Canton, Ohio, United States
Cleveland Clinic - Main Campus
Cleveland, Ohio, United States
Apex Clinical Research Center
Mayfield Heights, Ohio, United States
SSM Health Dermatology
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
North Texas Center for Clinical Research
Frisco, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Hopital Avicenne
Bobigny, France
Centre Hospitalier Universitaire De Nantes
Nantes, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Ludwig-Maximilians-Universitaet Muenchen (LMU) - Klinik und Poliklinik fuer Dermatologie und Allergologie
Munich, Bavaria, Germany
Charité Universitätsmedizin Berlin - Campus Charité Mitte
Berlin, Germany
DRK Gemeinnützige Krankenhaus GmbH Sachsen
Chemnitz, Germany
ASST Spedali Civili di Brescia
Brescia, Italy
AOU Maggiore della Carita
Novara, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
Maastricht University Medical Center
Maastricht, Netherlands
Hospital Clinic Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitartio 12 De Octubre
Madrid, Spain
The University of Birmingham
Birmingham, United Kingdom
Barts Health NHS Trust - The Royal London Hospital
London, United Kingdom
Northern Care Alliance NHS Foundation Trust
Salford, United Kingdom