A 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

Stopped early · Phase 2

Conditions studied: Recurrent Basal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT04155190

Run by

Sol-Gel Technologies, Ltd.

People needed

50

Starts

2019-12-20

Expected to finish

2021-04-23

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Axiom Research, LLC — Apple Valley, California, United States
• Axiom Research, LLC — Colton, California, United States
• Center for Dermatology Clinical Research, Inc. — Fremont, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• The Dermatology Center of Newport — Newport Beach, California, United States
• Palm Beach Dermatology Research — Delray Beach, Florida, United States
• Leavitt Medical Associates of Florida — Ormond Beach, Florida, United States
• PellePharm Investigative Site — Saint Augustine, Florida, United States
• The Indiana Clinical Trials Center — Plainfield, Indiana, United States
• Grekin Skin Institute — Warren, Michigan, United States
• PellePharm Investigative Site — Henderson, Nevada, United States
• Skin Laser and Surgery Specialists of NY&NJ — Hackensack, New Jersey, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Utah — Murray, Utah, United States

Full record on ClinicalTrials.gov

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