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Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome
Trial Status: closed to accrual
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.
Inclusion Criteria
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. Key
Exclusion Criteria
The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study Investigational Product (IP).
The subject is known to have hypersensitivity to any of the ingredients in the IP formulation.
The subject has uncontrolled systemic disease.
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.
Inefficacy of previous Hedgehog inhibitor therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06050122.
Locations matching your search criteria
United States
Connecticut
New Haven
Yale University
Status: Active
Name Not Available
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
North Carolina
Durham
Duke University Medical Center
Status: Active
Name Not Available
This is a global, multicenter, randomized, double-blind, stratified, vehicle-controlled
study of the efficacy and safety of Patidegib Gel 2%, applied topically twice daily to
the face of adult subjects with Gorlin syndrome.
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
