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Patidegib Gel 2% (w/w), applied topically to the face twice daily for 12 months

Vehicle Gel, applied topically to the face twice daily for 12 months

Patidegib Gel 2% is a smooth, clear, colorless-to-yellow, viscous, hydro-alcoholic gel for topical administration.

Patidegib Topical Gel

Vehicle Gel consists of the excipients of Patidegib Gel with no active patidegib. It is a smooth viscous gel for topical administration.

Patidegib Topical Gel with no active patidegib

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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.

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 participants with Gorlin syndrome.

Participants will be randomized (1:1) to receive either Patidegib Gel 2% or Vehicle Gel for 12 months. The assignment of participants to the 2 groups will be stratified by sex assigned at birth, age (≥60 or \<60 years), and number of facial BCC lesions (10-15, 16-30 or \>30) at baseline.

All BCCs at baseline, and any new BCCs which develop during the study, will be photographed and tracked during the study. New BCCs will be confirmed by dermoscopy analysis.

Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome

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

New BCCs, confirmed through dermoscopy, at Month 12 after twice-daily treatment with either Patidegib Gel 2% or Vehicle Gel for 12 months

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Sol-Gel Technologies, Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome	NCT06050122	Gorlin Syndrome	Patidegib Topic... Patidegib Topic...	18 Years -	Sol-Gel Technologies, Ltd.
Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome	NCT06050122	Gorlin Syndrome	Patidegib Topic... Patidegib Topic...	18 Years -	Sol-Gel Technologies, Ltd.

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