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
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Sol-Gel Technologies, Ltd.
- Enrollment
- 50
- Locations
- 24
- Primary Endpoint
- Number of new surgically eligible BCCs (nSEBs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
As a double-blinded study, the Investigators, the site staff, PellePharm, and the Clinical Monitor(s) will be blinded to the treatment assigned to individual subjects. Delegated staff members at the study site will dispense the investigational product (IP) and will collect and weigh all used and unused IP tubes.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Patidegib Topical Gel, 2%
Participants will be randomized (1:1) to receive Patidegib Topical Gel, 2% for 9 months
Intervention: Patidegib Topical Gel, 2% (Drug)
Patidegib Topical Gel, Vehicle
Participants will be randomized (1:1) to receive Patidegib Topical Gel, Vehicle for 9 months
Intervention: Patidegib Topical Gel, Vehicle (Drug)
Outcomes
Primary Outcomes
Number of new surgically eligible BCCs (nSEBs)
Time Frame: Baseline through Month 9
Number of Participants With New Surgically Eligible Basal Cell Carcinomas (nSEBs)
Time Frame: Up to 9 months
Secondary Outcomes
- Number of treatment emergent adverse events assessed with means and standard errors or proportions(Baseline through Month 9)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Up to 9 months)