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New gel could slash facial skin cancers in rare genetic condition

NCT ID NCT06050122

Disease control Sponsor: Sol-Gel Technologies, Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This Phase 3 study tests whether a gel containing patidegib can lower the number of new basal cell carcinomas (a type of skin cancer) on the face of adults with Gorlin syndrome. Participants apply the gel or a placebo to their face twice daily for a year. The study will compare how many new cancers appear between the two groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Patidegib gel 2%
What this could lead to
If it works, this could provide a topical treatment to reduce the number of new skin cancers on the face for people with Gorlin syndrome.
What could go wrong
This is a relatively small Phase 3 trial (140 people). The gel may not significantly reduce new BCCs compared to placebo, and long-term safety is not yet established.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

113 people

The number who actually took part.

Started

Mar 2024

Finished

Sep 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. The subject must be at least 18 years old at the Screening Visit. 2. The subject must be confirmed to have a PTCH1 mutation. 3. The subject must have at least 10 BCCs on the face at Randomization (Baseline/Day 1). 4. The subject must be willing to abstain from application of any non-study topical medication (prescription or over the counter) to their facial skin for the duration of the trial, except as prescribed by the investigator. Key Exclusion Criteria: 1. The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study Investigational Product (IP). 2. The subject is known to have hypersensitivity to any of the ingredients in the IP formulation. 3. The subject has uncontrolled systemic disease. 4. The subject has been treated for invasive cancer within the past 5 years excluding chronic lymphocytic leukemia Stage 0, non-melanoma skin cancer, successfully treated melanoma in situ and Stage I melanoma, Stage I cervical cancer, or ductal carcinoma in situ of the breast. 5. Inefficacy of previous Hedgehog inhibitor therapy.

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Conditions

The condition(s) this trial relates to.

nevoid basal cell carcinoma syndrome basal cell carcinoma prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gorlin syndrome

Contacts and locations

Locations

  • AOU Maggiore della Carita

    Novara, Italy

  • ASST Spedali Civili di Brescia

    Brescia, Italy

  • Apex Clinical Research Center

    Canton, Ohio, 44718, United States

  • Apex Clinical Research Center

    Mayfield Heights, Ohio, 44124, United States

  • Barts Health NHS Trust - The Royal London Hospital

    London, United Kingdom

  • Center for Dermatology Clinical Research

    Fremont, California, 94538, United States

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, France

  • Centre Hospitalier Universitaire De Nantes

    Nantes, France

  • Charité Universitätsmedizin Berlin - Campus Charité Mitte

    Berlin, Germany

  • Cleveland Clinic - Main Campus

    Cleveland, Ohio, 44195, United States

  • DRK Gemeinnützige Krankenhaus GmbH Sachsen

    Chemnitz, Germany

  • Dermatology Associates of Tallahassee

    Tallahassee, Florida, 32308, United States

  • Duke University Health System

    Durham, North Carolina, 27710, United States

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Italy

  • Hopital Avicenne

    Bobigny, France

  • Hospital Clinic Barcelona

    Barcelona, Spain

  • Hospital Universitartio 12 De Octubre

    Madrid, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Spain

  • Ludwig-Maximilians-Universitaet Muenchen (LMU) - Klinik und Poliklinik fuer Dermatologie und Allergologie

    Munich, Bavaria, Germany

  • Maastricht University Medical Center

    Maastricht, Netherlands

  • MediSearch Clinical Trials

    Saint Joseph, Missouri, 64506, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Minnesota Clinical Study Center

    New Brighton, Minnesota, 55112, United States

  • North Texas Center for Clinical Research

    Frisco, Texas, 75034, United States

  • Northern Care Alliance NHS Foundation Trust

    Salford, United Kingdom

  • Northwest Arkansas Clinical Trials Center

    Rogers, Arkansas, 72758, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • SSM Health Dermatology

    Oklahoma City, Oklahoma, 73102, United States

  • Schweiger Dermatology P.C.

    Verona, New Jersey, 07044, United States

  • Stanford University - Lucille Packard's Children's Hospital

    Redwood City, California, 94063, United States

  • The Dermatology Center of Newport

    Newport Beach, California, 92660, United States

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287-0006, United States

  • The University of Birmingham

    Birmingham, United Kingdom

  • The University of Chicago Medicine

    Chicago, Illinois, 60637, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of California Los Angeles (UCLA) - Center for Inflammatory Bowel Diseases - Westwood Location

    Los Angeles, California, 90024, United States

  • University of Michigan Health - Michigan Medicine - University Hospital

    Ann Arbor, Michigan, 48109, United States

  • University of South Florida Health

    Tampa, Florida, 33612, United States

  • Yale University

    New Haven, Connecticut, 06519, United States