Phase 3 Efficacy and Safety for Reduction of Disease Burden of Basal Cell Carcinomas
Research type
Research Study
Full title
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.
IRAS ID
1009110
Contact name
Ofra Levy-Hachman
Contact email
Sponsor organisation
Sol-Gel Technologies Ltd.
Clinicaltrials.gov Identifier
Research summary
This is a Randomized, Double-blind, Vehicle-controlled Phase 3 study in participants with Gorlin Syndrome. The participants will be split into 2 groups. one group applies Patidegib topical gel 2% to their face twice a day for 12 months and the other group applies vehicle gel to their face twice a day. The study will involve various assessments, including demographic information, medical history, prior and concomitant medication use. The main goal of this study is to determine whether Patidegib Gel, applied twice daily to the face, can reduce the number of new basal cell carcinomas (BCCs) in individuals with Gorlin Syndrome.
Efficacy assessments will include imaging and measurement of BCCs which will be reviewed by a central board, biopsies, and patient-reported outcome assessments. Safety assessments will focus on dermal safety and tolerability, adverse events monitoring, laboratory tests, physical examinations, and pregnancy tests for eligible participants.REC name
London - City & East Research Ethics Committee
REC reference
24/LO/0015
Date of REC Opinion
1 Feb 2024
REC opinion
Further Information Favourable Opinion