At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-blind, Vehicle-controlled, Phase 3 Efficacy and Safety 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
In Brief
A Phase 3 clinical trial evaluating Patidegib Topical Gel, 2% and Patidegib Topical Gel, Vehicle for Basal Cell Nevus Syndrome. Completed, enrolled 174 participants across 49 sites in 10 countries.
Detailed 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.
Study Details
Timeline
Interventions
Patidegib Topical Gel, 2%
Patidegib Topical Gel, Vehicle