Efficacy, Safety and Tolerability of Topically Applied LDE225 Cream (Hedgehog Pathway Inhibitor) in Adult Patients With Nevoid Basal Cell Carcinoma Syndrome (NBCCS)

Exclusion Criteria

• •1. Any concomitant dermatological disease that could confound the evaluations, based on the discretion of the investigator.
• •2. Prior exposure to LDE225.
• •3. Use of systemic treatment for BCC in the 4 weeks prior to Baseline.
• •4. Use of topical treatment or photodynamic therapy (PDT) in the 12 weeks prior to Baseline.
• •5. Use of other investigational drugs at Baseline, or within 30 days or 5 half-lives prior to Baseline, whichever is longer.
• •6. Clinically significant medical condition, as per judgment of the investigator.
• •7. History of hypersensitivity to any of the ingredient of the study drug.
• •8. Pregnant or nursing (lactating) women
• •9. Women of child-bearing potential and fertile males, UNLESS they are using two birth control methods