Site for A Multicenter, Phase 2B, Randomized, Double-Blind, Stratified, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Sirolimus 3.9% Topical Gel in Prevention of BCCs in Patients with Gorlin Syndrome
Gorlin Syndrome: Topical gel applied daily before bedtime. Approximately 32 week participation. 18 years and older meeting diagnostic criteria for Gorlin Syndrome. The goal of this study is to compare the number of new biopsy confirmed BCCs that develop over a 6-month period between the treatment arms, active and placebo (no active indgredient). This study will also include disease burden assessments (questionnaires) at various timepoints.
Participants will participate in a total of 8 visits over approximately 32 weeks. 5 visits will be conducted in person while the other 3 will be completed via phone call. Also, throughout the study and at different time points you will have your skin examined, blood drawn, have an ECG, and have a shave biopsy as well as complete questionnaires.
study coordinator will discuss.
Willing to have blood collected.
Willing to follow all study instructions.
Must have had at least 10 basal cells present on the face, scalp, and/or neck within past 24 months.
Certain Medications are not allowed; study coordinator will discuss.
Previously participated in a clinical trial evaluating an investigational product for treatment of BCCs or GS within the past 3 months.