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

Overview

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.

Full Title of Study: “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”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Triple (Participant, Care Provider, Investigator)
• Study Primary Completion Date: April 23, 2021

Interventions

• Drug: Patidegib Topical Gel, 2%
  • Patidegib Topical Gel, 2%
• Drug: Patidegib Topical Gel, Vehicle
  • Patidegib Topical Gel, Vehicle

Arms, Groups and Cohorts

• Experimental: Patidegib Topical Gel, 2%
  • Participants will be randomized (1:1) to receive Patidegib Topical Gel, 2% for 9 months
• Active Comparator: Patidegib Topical Gel, Vehicle
  • Participants will be randomized (1:1) to receive Patidegib Topical Gel, Vehicle for 9 months

Clinical Trial Outcome Measures

Primary Measures

• Number of new surgically eligible BCCs (nSEBs)
  • Time Frame: Baseline through Month 9

Secondary Measures

• Number of treatment emergent adverse events assessed with means and standard errors or proportions
  • Time Frame: Baseline through Month 9

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Sol-Gel Technologies, Ltd.
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • VP, Clinical Operations, Study Director, PellePharm, Inc.