Recurrent Basal Cell Carcinoma Clinical Trial
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
| Verified date | May 2023 |
| Source | Sol-Gel Technologies, Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 47 |
| Est. completion date | April 23, 2021 |
| Est. primary completion date | April 23, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. 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). 2. 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. Exclusion Criteria: 1. The subject has been previously diagnosed with Gorlin syndrome 2. On medical history, family history or clinical examination there is a suspicion that the patient has Gorlin syndrome. 3. Patients with a family history of medulloblastoma 4. The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP. 5. The subject has uncontrolled systemic disease. 6. 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Axiom Research, LLC | Apple Valley | California |
| United States | Axiom Research, LLC | Colton | California |
| United States | Palm Beach Dermatology Research | Delray Beach | Florida |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Center for Dermatology Clinical Research, Inc. | Fremont | California |
| United States | Skin Laser and Surgery Specialists of NY&NJ | Hackensack | New Jersey |
| United States | PellePharm Investigative Site | Henderson | Nevada |
| United States | Dermatology Research Associates | Los Angeles | California |
| United States | University of Utah | Murray | Utah |
| United States | The Dermatology Center of Newport | Newport Beach | California |
| United States | Leavitt Medical Associates of Florida | Ormond Beach | Florida |
| United States | The Indiana Clinical Trials Center | Plainfield | Indiana |
| United States | PellePharm Investigative Site | Saint Augustine | Florida |
| United States | Grekin Skin Institute | Warren | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Sol-Gel Technologies, Ltd. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of new surgically eligible BCCs (nSEBs) | Baseline through Month 9 | ||
| Secondary | Number of treatment emergent adverse events assessed with means and standard errors or proportions | Baseline through Month 9 |