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

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 topicalmedication (prescription or over the counter) to their facial skin for the durationof 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 mightinterfere with the evaluation of the study Investigational Product (IP).

2. The subject is known to have hypersensitivity to any of the ingredients in the IPformulation.

3. The subject has uncontrolled systemic disease.

4. The subject has been treated for invasive cancer within the past 5 years excludingchronic lymphocytic leukemia Stage 0, non-melanoma skin cancer, successfully treatedmelanoma in situ and Stage I melanoma, Stage I cervical cancer, or ductal carcinomain situ of the breast.

5. Inefficacy of previous Hedgehog inhibitor therapy.