A Multicenter, Randomized, Double blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects with Basal Cell Nevus Syndrome
- Conditions
- skin cancer1004078910040900
- Registration Number
- NL-OMON55856
- Lead Sponsor
- PellePharm, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
Key
1. The subject must be at least 18 years old at the Screening visit.
2. The subject must meet diagnostic criteria for BCNS (Inclusion Criteria 3).
3. The subject must have had at least 10 (with at least 3 on the face)
clinically typical BCCs present within 24 months prior to Randomization
(Baseline/Day 1). Additionally, the subject must have at least 2 BCCs with
longest diameter <5 mm present on the face prior to randomization.
4. 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.
Key
1. The subject has used topical treatment to the face or systemic therapies
that might interfere with the evaluation of the study IP.
2. The subject is known to have a hypersensitivity to any of the ingredients in
the IP.
3. The subject has uncontrolled systemic disease.
4. 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
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the number of new BCCs per subject by Month 12.</p><br>
- Secondary Outcome Measures
Name Time Method