Active — Not RecruitingPhase 3

Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome

United States140 participantsStarted 2024-03-17

Plain-language summary

The aim of this clinical study is to find out how well Patidegib Gel 2% works in preventing new basal cell carcinomas (BCCs) developing on the face of adults with Gorlin syndrome, and how safe Patidegib Gel 2% is to use. People who take part will apply either Patidegib Gel 2% or a Vehicle Gel (with no active drug substance) to their face twice a day for a year (12 months). The number of new BCCs on the face will be compared between those who used Patidegib Gel 2% or Vehicle Gel after 12 months.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. The subject must be at least 18 years old at the Screening Visit.
✓. The subject must be confirmed to have a PTCH1 mutation.
✓. The subject must have at least 10 BCCs on the face at Randomization (Baseline/Day 1).
✓. 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.

Exclusion criteria

✕. The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study Investigational Product (IP).
✕. The subject is known to have hypersensitivity to any of the ingredients in the IP formulation.
✕. The subject has uncontrolled systemic disease.
✕. 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.
✕. Inefficacy of previous Hedgehog inhibitor therapy.

What they're measuring

Number of new BCCs on the face at Month 12

Timeframe: Month 12

Trial details

NCT IDNCT06050122

SponsorSol-Gel Technologies, Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08

View on ClinicalTrials.gov More Gorlin Syndrome trials