Clinical Trial: Efficacy, Safety and Tolerability of Topically Applied LDE225 Cream (Hedgehog Pathway Inhibitor) in Adult Patients With Nevoid Basal Cell Carcinoma Syndrome (NBCCS)
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
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 Same as current
Current Secondary Outcome:
- To assess the safety of topical treatment with LDE225, compared to vehicle. Measure: Reported systemic adverse events in patients with NBCCS [ Time Frame: Treatment phase and up to 4 weeks after LDE225 treatment ]
- To evaluate the local tolerability of topical treatment with LDE225, compared to vehicle. Measure:Reported local adverse events in patients with NBCCS [ Time Frame: Treatment phase and up to 4 weeks after LDE225 treatment ]
- To assess the rate of complete clinical clearance of BCCs in patients with NBCCS. Measure: No clinical residual signs of carcinoma [ Time Frame: 4 weeks after LDE225 treatment ]
- To assess the rate of complete histological clearance of BCCs in patients with NBCCS. Measure: No residual tumor tissue [ Time Frame: 4 weeks after LDE225 treatment ]
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: July 6, 2010
Date Started:
Date Completion:
Last Updated: May 3, 2017
Last Verified: February 2017
