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

June 22, 2026 updated by: Sol-Gel Technologies, Ltd.

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Apple Valley, California, United States, 92307
        • Axiom Research, LLC
      • Colton, California, United States, 92324
        • Axiom Research, LLC
      • Fremont, California, United States, 94538
        • Center For Dermatology Clinical Research, Inc.
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • Newport Beach, California, United States, 92660
        • The Dermatology Center of Newport
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Palm Beach Dermatology Research
      • Ormond Beach, Florida, United States, 32174
        • Leavitt Medical Associates of Florida
      • Saint Augustine, Florida, United States, 32080
        • PellePharm Investigative Site
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center
    • Michigan
      • Warren, Michigan, United States, 48088
        • Grekin Skin Institute
    • Nevada
      • Henderson, Nevada, United States, 89052
        • PellePharm Investigative Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Skin Laser and Surgery Specialists of NY&NJ
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Utah
      • Murray, Utah, United States, 84107
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • IP
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:
  • IP, Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With New Surgically Eligible Basal Cell Carcinomas (nSEBs)
Time Frame: Up to 9 months
Up to 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to 9 months
TEAEs were defined as AEs that started on or after the first dose of study drug. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
Up to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sol-Gel Technologies, Ltd.

Investigators

  • Study Director: VP, Clinical Operations, PellePharm, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2019

Primary Completion (Actual)

April 23, 2021

Study Completion (Actual)

April 23, 2021

Study Registration Dates

First Submitted

November 1, 2019

First Submitted That Met QC Criteria

November 5, 2019

First Posted (Actual)

November 7, 2019

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pelle-926-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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