An Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas in Patients With Non-Gorlin High Frequency BCC

This is an interventional treatment trial for Recurrent Basal Cell Carcinoma focused on measuring High Frequency Basal Cell Carcinoma, non-gorlin, HF-BCC, Bazex-Dupré-Christol Syndrome, Rombo Syndrome, Oley Syndrome, Xeroderma Pigmentosum (XP) Syndrome, BCC, SEB, Hedgehog inhibitor, Basal Cell Nevus Syndrome, Basal Cell Carcinoma, Surgically Eligible Basal Cell Carcinoma, patidegib, HFBCC, HHI Read More

Inclusion Criteria:

1. The subject must have had at least 10 (with at least 3 on the face) clinically typical BCCs present within 24 months prior to Screening and Randomization (Baseline/Day 1). Additionally, the subject must have at least 2 BCCs with longest diameter <5 mm present on the face prior to Screening and Randomization (Baseline/Day 1).
2. The subject must be willing to abstain from application of a non-study topical medication (prescription or over the counter) to facial skin for the duration of the trial except as prescribed by the Investigator.

Exclusion Criteria:

1. The subject has been previously diagnosed with Gorlin syndrome
2. On medical history, family history or clinical examination there is a suspicion that the patient has Gorlin syndrome.
3. Patients with a family history of medulloblastoma
4. The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP.
5. The subject has uncontrolled systemic disease.
6. The subject has been treated for invasive cancer within the past 5 years excluding non-melanoma skin cancer, Stage I cervical cancer, ductal carcinoma in situ of the breast, or chronic lymphocytic leukemia (CLL) Stage 0.