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Double-blind, Randomized, Vehicle-controlled Proof of Concept Study on the Efficacy, Safety, Local Tolerability, PK and Pharmacodynamics of Multiple Topical Administrations of LDE225 on Sporadic Superficial and Nodular Skin Basal Cell Carcinomas
This was a double-blinded, randomized, vehicle-controlled study in sporadic superficial BCC (sBCC) and nodular BCC (nBCC) patients which consisted of a 21-day screening period, a treatment period of 6 weeks (topical 0.75% LDE225 cream application b.i.d) ending with post treatment biopsies, as safety visit one week after final study drug administration (Day 50), a visit on Day 83 for excision of the treated BCC, and an end of study evaluation (Day 90).
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Benowa, Queensland, Australia
Novartis Investigative Site
Woolloongabba, Queensland, Australia
Novartis Investigative Site
Graz, Austria
Novartis Investigative Site
Vienna, Austria
Start Date
December 1, 2009
Primary Completion Date
February 1, 2011
Completion Date
February 1, 2011
Last Updated
October 30, 2015
25
ACTUAL participants
LDE225 0.75%
DRUG
Vehicle
DRUG
Lead Sponsor
Novartis Pharmaceuticals
Data Source & Attribution
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