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
- Conditions
- Recurrent Basal Cell Carcinoma
- Interventions
- Registration Number
- NCT04155190
- Lead Sponsor
- Sol-Gel Technologies, Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 47
- The subject must have had at least 10 (with at least 3 on the face) clinically typical BCCs present within 24 months prior to Screening and Randomization (Baseline/Day 1). Additionally, the subject must have at least 2 BCCs with longest diameter <5 mm present on the face prior to Screening and Randomization (Baseline/Day 1).
- The subject must be willing to abstain from application of a non-study topical medication (prescription or over the counter) to facial skin for the duration of the trial except as prescribed by the Investigator.
- The subject has been previously diagnosed with Gorlin syndrome
- On medical history, family history or clinical examination there is a suspicion that the patient has Gorlin syndrome.
- Patients with a family history of medulloblastoma
- The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP.
- The subject has uncontrolled systemic disease.
- The subject has been treated for invasive cancer within the past 5 years excluding non-melanoma skin cancer, Stage I cervical cancer, ductal carcinoma in situ of the breast, or chronic lymphocytic leukemia (CLL) Stage 0.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patidegib Topical Gel, 2% Patidegib Topical Gel, 2% Participants will be randomized (1:1) to receive Patidegib Topical Gel, 2% for 9 months Patidegib Topical Gel, Vehicle Patidegib Topical Gel, Vehicle Participants will be randomized (1:1) to receive Patidegib Topical Gel, Vehicle for 9 months
- Primary Outcome Measures
Name Time Method Number of new surgically eligible BCCs (nSEBs) Baseline through Month 9
- Secondary Outcome Measures
Name Time Method Number of treatment emergent adverse events assessed with means and standard errors or proportions Baseline through Month 9
Trial Locations
- Locations (12)
The Dermatology Center of Newport
🇺🇸Newport Beach, 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
Leavitt Medical Associates of Florida
🇺🇸Ormond Beach, Florida, United States
Skin Laser and Surgery Specialists of NY&NJ
🇺🇸Hackensack, New Jersey, United States
Grekin Skin Institute
🇺🇸Warren, Michigan, United States
University of Utah
🇺🇸Murray, Utah, United States
Palm Beach Dermatology Research
🇺🇸Delray Beach, Florida, United States
PellePharm Investigative Site
🇺🇸Henderson, Nevada, United States
The Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States