Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome
NCT ID: NCT06050122
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
140 participants
INTERVENTIONAL
2024-03-17
2026-08-31
Brief Summary
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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.
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Detailed Description
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Subjects will be randomized (1:1) to receive either Patidegib Gel 2% or Vehicle Gel for 12 months.
The assignment of subjects to the 2 groups will be stratified by sex assigned at birth, age (≥60 or \<60 years), and number of BCC lesions at the treatment area (face) (10-15, 16-30 or \>30) at Baseline.
All suspicious lesions will be imaged and tracked consistently throughout the study so that new BCCs that arise can be readily identified. New BCCs will be confirmed by dermoscopic analysis through the study. The BCC images will be reviewed and assessed by a Central Photo Review Board (CPRB).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Patidegib Gel 2%
Patidegib Gel 2% (w/w), applied topically to the face twice daily for 12 months
Patidegib Topical Gel
Patidegib Gel 2% is a smooth, clear, colorless-to-yellow, viscous, hydro-alcoholic gel for topical administration.
Vehicle Gel
Vehicle Gel, applied topically to the face twice daily for 12 months
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Sol-Gel Technologies, Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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2023-507528-21-00
Identifier Type: OTHER
Identifier Source: secondary_id
SGT-610-01
Identifier Type: -
Identifier Source: org_study_id
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