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Using Patidegib Gel to prevent skin cancers in adults with Gorlin Syndrome

A Multicenter, Randomized, Double Blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Gel 2% for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects with Gorlin Syndrome

Phase 3 Interventional Sol-Gel Technologies, Ltd. · NCT06050122

This study is testing if applying Patidegib Gel can help adults with Gorlin syndrome prevent new skin cancers on their faces.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment140 (estimated)
Ages18 Years and up
SexAll
SponsorSol-Gel Technologies, Ltd. Industry-sponsored
Locations43 sites (Rogers, Arkansas and 42 other locations)
Trial IDNCT06050122 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the effectiveness and safety of Patidegib Gel 2% in preventing new basal cell carcinomas (BCCs) on the faces of adults diagnosed with Gorlin syndrome. Participants will apply either Patidegib Gel or a placebo vehicle gel to their face twice daily for a year. The study is designed as a randomized, double-blind, vehicle-controlled trial, with participants stratified by sex, age, and number of existing BCCs. The primary outcome will be the comparison of new BCC occurrences between the two groups after 12 months.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed PTCH1 mutation and at least 10 basal cell carcinomas on their face.

Not a fit: Patients with uncontrolled systemic diseases or those who have had invasive cancer treatment in the past five years may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of basal cell carcinomas in patients with Gorlin syndrome.

How similar studies have performed: While this approach is novel for Gorlin syndrome, similar topical treatments have shown promise in preventing skin cancers in other populations.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Rogers, Arkansas and 42 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Gorlin Syndrome
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.