drugset / Trial / NCT03703310

Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome (Gorlin Syndrome)

NCT03703310

Phase 3 Completed 174 enrolled Sol-Gel Technologies, Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a global, multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult participants with Gorlin syndrome. Participants will be required to apply the investigational product for 12 months. The primary endpoint is a comparison between the two treatment arms of the number of new BCCs that develop over the 12 month period.

Timeline

Start
2019-02-19
Primary completion
2020-12-28
Completion
2020-12-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Patidegib Small molecule 2 % Topical