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)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Sol-Gel Technologies, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

An open-label, extension safety and tolerability study is planned for at least 12 months duration following the end of this study. All participants who complete the Month 12 Exit Visit having demonstrated adequate compliance with application of the Investigational Product (IP) without major Protocol Deviations (PDs) during the study will be eligible for participation in the extension study. All participants will be contacted by phone approximately 30 days following the Exit or Discontinuation Visit to determine if the participant has experienced any new adverse events (AEs)/serious AEs (SAEs) since discontinuation/completion of study treatment.

Conditions

• Basal Cell Nevus Syndrome

Interventions

Type	Name	Description
DRUG	Patidegib Topical Gel, 2%	Patidegib Topical Gel, 2%
DRUG	Patidegib Topical Gel, Vehicle	Patidegib Topical Gel, Vehicle

Timeline

• Start date: 2019-02-19
• Primary completion: 2020-12-28
• Completion: 2020-12-28
• First posted: 2018-10-11
• Last updated: 2024-07-03
• Results posted: 2024-07-03

Locations

49 sites across 10 countries: United States, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study