Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome
Trial ID or NCT#
Status
RECRUITING
Purpose
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. Participants 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 participants 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
Eligibility Criteria
- 1. The subject must be at least 18 years old at the Screening Visit.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.
- Key
- 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. 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 and non-melanoma skin cancer, Stage I cervical cancer, or ductal carcinoma in situ of the breast.5. Previous Hedgehog inhibitor therapy was considered to have failed for reasons other than unfavorable side effect(s).
Investigator(s)
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Contact
Mahrukh Abdullah
View on ClinicalTrials.gov
