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
Status: Active_not_recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arkansas
Northwest Arkansas Clinical Trials Center
Rogers
California
Center for Dermatology Clinical Research
Fremont
University of California Los Angeles (UCLA) - Center for Inflammatory Bowel Diseases - Westwood Location
Los Angeles
The Dermatology Center of Newport
Newport Beach
Stanford University - Lucille Packard's Children's Hospital
Redwood City
Connecticut
Yale University
New Haven
Florida
Dermatology Associates of Tallahassee
Tallahassee
University of South Florida Health
Tampa
Illinois
The University of Chicago Medicine
Chicago
Maryland
The Johns Hopkins Hospital
Baltimore
Michigan
University of Michigan Health - Michigan Medicine - University Hospital
Ann Arbor
Minnesota
Minnesota Clinical Study Center
New Brighton
Missouri
MediSearch Clinical Trials
Saint Joseph
North Carolina
Duke University Health System
Durham
New Jersey
Schweiger Dermatology P.C.
Verona
New York
Memorial Sloan Kettering Cancer Center
New York
Ohio
Apex Clinical Research Center
Canton
Cleveland Clinic - Main Campus
Cleveland
Apex Clinical Research Center
Mayfield Heights
Oklahoma
SSM Health Dermatology
Oklahoma City
Oregon
Oregon Health and Science University
Portland
Pennsylvania
Penn State Hershey Medical Center
Hershey
Texas
North Texas Center for Clinical Research
Frisco
The University of Texas MD Anderson Cancer Center
Houston
Other Locations
France
Hopital Avicenne
Bobigny
Centre Hospitalier Universitaire De Nantes
Nantes
Centre Hospitalier Lyon Sud
Pierre-bénite
Germany
Charité Universitätsmedizin Berlin - Campus Charité Mitte
Berlin
DRK Gemeinnützige Krankenhaus GmbH Sachsen
Chemnitz
Ludwig-Maximilians-Universitaet Muenchen (LMU) - Klinik und Poliklinik fuer Dermatologie und Allergologie