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Study on Patidegib Gel for Reducing Basal Cell Carcinomas in Adults with Gorlin Syndrome

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Gorlin Syndrome, which is a genetic disorder that can lead to the development of multiple skin cancers called Basal Cell Carcinomas (BCCs). The study is testing a treatment called Patidegib Gel 2%, which is applied directly to the skin. The purpose of the study is to evaluate how effective and safe this gel is in reducing the number of BCCs that develop on the face of adults with Gorlin Syndrome.

Participants in the study will be randomly assigned to use either the Patidegib Gel or a Vehicle Gel, which does not contain the active medication. The study will last for 12 months, during which participants will apply the gel twice daily to their face. Throughout the study, the number of new BCCs will be monitored, along with any changes in the size of existing BCCs and any side effects experienced by the participants.

The study aims to determine if Patidegib Gel can effectively reduce the burden of BCCs in individuals with Gorlin Syndrome, potentially offering a new way to manage this condition. Participants will be closely monitored by healthcare professionals to ensure their safety and to gather data on the gel's effectiveness in preventing new BCCs from forming.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, confirmation of a PTCH1 mutation is required. This is a genetic marker associated with Gorlin Syndrome.

    At least 10 Basal Cell Carcinomas (BCCs) must be present on the face at the start of the study.

  2. Step 2

    Medication administration

    The study involves the application of Patidegib Gel 2% or a Vehicle Gel to the face.

    The gel is applied twice daily for the duration of the study.

  3. Step 3

    Treatment duration

    The treatment is conducted over a period of 12 months.

    During this time, no other topical medications should be applied to the facial skin unless prescribed by the study investigator.

  4. Step 4

    Primary assessment

    The primary goal is to assess the number of new BCCs at the end of the 12-month period.

    This assessment is conducted for both the Patidegib Gel 2% and the Vehicle Gel groups.

  5. Step 5

    Secondary assessments

    Secondary assessments include evaluating the number of new surgically eligible BCCs, changes in lesion symptoms, and lesion diameter.

    Other assessments involve the resolution and regression of BCCs, quality of life changes, and any adverse events.

  6. Step 6

    Safety and tolerability

    Throughout the trial, safety and local tolerability of the treatment are monitored.

    This includes recording any adverse events or serious adverse events.

Who can join the trial?

4 criteria

  • The subject must be at least 18 years old at the Screening Visit.
  • The subject must be confirmed to have a PTCH1 mutation. This is a specific change in a gene that is linked to Gorlin Syndrome.
  • The subject must have at least 10 BCCs on the face at Randomization (Baseline/Day 1). BCCs are a type of skin growth called basal cell carcinomas.
  • The subject must be willing to abstain from applying 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.

Who cannot join the trial?

4 criteria

  • Individuals who do not have **Gorlin Syndrome** cannot participate. **Gorlin Syndrome** is a genetic condition that can cause skin issues and other health problems.
  • Participants must be within a specific age range, which is not specified here, but typically includes children and adults.
  • Both males and females are eligible, but certain health conditions or treatments might exclude someone.
  • People who are considered part of a **vulnerable population** may be excluded. A **vulnerable population** includes groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

Patidegib Gel is a topical medication being studied for its ability to reduce the number of basal cell carcinomas (BCCs) in people with Gorlin syndrome. It is applied to the skin, specifically on the face, twice a day. The goal of using this gel is to see if it can effectively decrease the disease burden by preventing the development of new BCCs in patients with this condition.

What is already known about the treatment

Patidegib Gel – This medication is administered topically in the form of a gel, applied directly to the skin. It is currently being studied in clinical trials for its effectiveness in treating Gorlin Syndrome, a condition that leads to the development of multiple basal cell carcinomas. Patidegib works by inhibiting a specific signaling pathway involved in the growth of these skin cancers. It belongs to the pharmacological class of hedgehog pathway inhibitors.

Investigated diseases

Gorlin Syndrome – Gorlin Syndrome, also known as Nevoid Basal Cell Carcinoma Syndrome, is a genetic disorder that affects various parts of the body. It is characterized by the development of multiple basal cell carcinomas, which are a type of skin cancer, often beginning in adolescence or early adulthood. Individuals with this syndrome may also have jaw cysts, skeletal abnormalities, and distinctive facial features. The condition is caused by mutations in a specific gene and is inherited in an autosomal dominant pattern. Over time, the number of skin lesions can increase, and other symptoms may become more pronounced. Regular monitoring and management are essential to address the various manifestations of the syndrome.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507528-21-00Protocol codeSGT-610-01Estimated enrolment156 patientsSponsorSol-Gel Technologies Ltd.

sourced from the EU Clinical Trials Register and site verification

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