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Brief Title: Efficacy, Safety and Tolerability of Topically Applied LDE225 Cream (Hedgehog Pathway Inhibitor) in Adult Patients With Nevoid Basal Cell Carcinoma Syndrome (NBCCS)
Official Title: A Randomized, Double-blind, Vehicle-controlled, Multicenter Trial of Topically Administered LDE225 Cream (0.75% Bid) to Evaluate Clearance of Basal Cell Carcinoma in Adult Patients With Nevoid Basal Cell Carcinoma Syndrome
Study ID: NCT03070691
Brief Summary: This 22 week study will assess the efficacy, safety, and tolerability of LDE225 versus vehicle when applied topically to basal cell carcinoma (BCC) in patients with NBCCS. Patients will treat multiple BCCs for up to 12 weeks. Treatment success is defined as complete clinical clearance and complete histological clearance in BCCs.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Novartis Investigative site, Bruxelles, , Belgium
Novartis Investigative site, Leuven, , Belgium
Novartis Investigative site, Waterloo, Ontario, Canada
Novartis Investigative site, Sainte-Foy, Quebec, Canada
Novartis Investigative site, Praha, , Czechia
Novartis Investigative site, Helsinki, , Finland
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Bonn, , Germany
Novartis Investigative Site, Dresden, , Germany
Novartis Investigative Site, Essen, , Germany
Novartis Investigative Site, Frankfurt, , Germany
Novartis Investigative Site, Heidelberg, , Germany
Novartis Investigative Site, Jena, , Germany
Novartis Investigative Site, Kiel, , Germany
Novartis Investigative Site, Luebeck, , Germany
Novartis Investigative Site, Mainz, , Germany
Novartis Investigative Site, Muenster, , Germany
Novartis Investigative Site, Munich, , Germany
Novartis Investigative Site, Recklinghausen, , Germany
Novartis Investigative Site, Tuebingen, , Germany
Novartis Investigative Site, Wuerzburg, , Germany
Novartis Investigative Site, Athens, , Greece
Novartis Investigative site, Thessaloniki, , Greece
Novartis Investigative site, Catania, , Italy
Novartis Investigative site, L'Aquila, , Italy
Novartis Investigative site, Napoli, , Italy
Novartis Investigative site, Padova, , Italy
Novartis Investigative site, Siena, , Italy
Novartis Investigative site, Barcelona, , Spain
Novartis Investigative site, Madrid, , Spain
Novartis Investigative site, Lausanne, , Switzerland
Novartis Investigative site, Zuerich, , Switzerland
Novartis Investigative site, Glasgow, , United Kingdom
Novartis Investigative site, London, , United Kingdom
Novartis Investigative site, Manchester, , United Kingdom
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR