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TERMINATED
NCT04155190
PHASE2

A 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

Sponsor: Sol-Gel Technologies, Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2019-12-20

Completion Date

2021-04-23

Last Updated

2026-07-21

Healthy Volunteers

No

Interventions

DRUG

Patidegib Topical Gel, 2%

Patidegib Topical Gel, 2%

DRUG

Patidegib Topical Gel, Vehicle

Patidegib Topical Gel, Vehicle

Locations (14)

Axiom Research, LLC

Apple Valley, California, United States

Axiom Research, LLC

Colton, California, United States

Center for Dermatology Clinical Research, Inc.

Fremont, California, United States

Dermatology Research Associates

Los Angeles, California, United States

The Dermatology Center of Newport

Newport Beach, California, United States

Palm Beach Dermatology Research

Delray Beach, Florida, United States

Leavitt Medical Associates of Florida

Ormond Beach, Florida, United States

PellePharm Investigative Site

Saint Augustine, Florida, United States

The Indiana Clinical Trials Center

Plainfield, Indiana, United States

Grekin Skin Institute

Warren, Michigan, United States

PellePharm Investigative Site

Henderson, Nevada, United States

Skin Laser and Surgery Specialists of NY&NJ

Hackensack, New Jersey, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Utah

Murray, Utah, United States