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
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Patidegib Topical Gel, 2% Participants will be randomized (1:1) to receive Patidegib Topical Gel, 2% for 9 months |
Drug: Patidegib Topical Gel, 2%
Patidegib Topical Gel, 2%
Other Names:
|
Active Comparator: Patidegib Topical Gel, Vehicle Participants will be randomized (1:1) to receive Patidegib Topical Gel, Vehicle for 9 months |
Drug: Patidegib Topical Gel, Vehicle
Patidegib Topical Gel, Vehicle
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of new surgically eligible BCCs (nSEBs) [Baseline through Month 9]
Secondary Outcome Measures
- Number of treatment emergent adverse events assessed with means and standard errors or proportions [Baseline through Month 9]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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).
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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:
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The subject has been previously diagnosed with Gorlin syndrome
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On medical history, family history or clinical examination there is a suspicion that the patient has Gorlin syndrome.
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Patients with a family history of medulloblastoma
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The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP.
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The subject has uncontrolled systemic disease.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Axiom Research, LLC | Apple Valley | California | United States | 92307 |
2 | Axiom Research, LLC | Colton | California | United States | 92324 |
3 | Center for Dermatology Clinical Research, Inc. | Fremont | California | United States | 94538 |
4 | Dermatology Research Associates | Los Angeles | California | United States | 90045 |
5 | The Dermatology Center of Newport | Newport Beach | California | United States | 92660 |
6 | Palm Beach Dermatology Research | Delray Beach | Florida | United States | 33484 |
7 | Leavitt Medical Associates of Florida | Ormond Beach | Florida | United States | 32174 |
8 | PellePharm Investigative Site | Saint Augustine | Florida | United States | 32080 |
9 | The Indiana Clinical Trials Center | Plainfield | Indiana | United States | 46168 |
10 | Grekin Skin Institute | Warren | Michigan | United States | 48088 |
11 | PellePharm Investigative Site | Henderson | Nevada | United States | 89052 |
12 | Skin Laser and Surgery Specialists of NY&NJ | Hackensack | New Jersey | United States | 07601 |
13 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
14 | University of Utah | Murray | Utah | United States | 84107 |
Sponsors and Collaborators
- PellePharm, Inc.
Investigators
- Study Director: VP, Clinical Operations, PellePharm, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pelle-926-203