NCT04155190

An Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas in Patients With Non-Gorlin High Frequency BCC

A Multicenter, Randomized, Double Blind, Vehicle-controlled, Phase 2 Efficacy and Safety Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Patients With Non-Gorlin High Frequency BCC

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Sol-Gel Technologies, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 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 non-Gorlin HF-BCC (high-frequency basal cell carcinoma). Participants will be randomized (1:1) to receive either Patidegib Topical Gel, 2%, or Vehicle for 9 months. Randomization will be stratified by gender. The primary endpoint is the number of nSEB (surgically eligible basal cell carcinoma) that develop on the face over the 9 month period. The primary end point will be assessed by imaging and tracking of BCCs consistently throughout the study in order to identify nSEBs.

Conditions

• Recurrent Basal Cell Carcinoma

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: 2019-12-20
• Primary completion: 2021-04-23
• Completion: 2021-04-23
• First posted: 2019-11-07
• Last updated: 2023-05-31

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study