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To Evaluate the Safety, Local Tolerability, PK and PD of LDE225 on Sporadic Superficial and Nodular Skin Basal Cell Carcinomas(sBCC)

2014-08-27 03:17:13 | BioPortfolio

Summary

A double-blind, randomized, vehicle-controlled Proof of Concept (PoC) study to evaluate the efficacy, safety, local tolerability, pharmacokinetics and pharmacodynamics of multiple topical administrations of LDE225 (a specific Smoothened inhibitor) on sporadic superficial and nodular skin basal cell carcinomas (superficial, sBCC) The study will consist of a 21-day screening period and a treatment period of 6 weeks ending with post treatment biopsies, followed by a safety visit one week after final drug administration (Day 50) and then by excision of the sBCC (Day 83) and a Study Completion evaluation (Day 90).

Patients will be exposed to multiple doses of topically applied LDE225 twice daily for 6 weeks in a double-blind manner. LDE225 and the vehicle as a negative control, will be randomized to the test areas. Shave biopsy may be performed pre-treatment to confirm diagnosis. Following the last application of the treatment, punch biopsies will be taken from the sBCC for biomarker and pharmacokinetics (lesional and perilesional) evaluation. In total 4 biopsies will be taken.

During treatment, the patients will return weekly for visits where each treated sBCC will be clinically evaluated and digital photographs taken. Local safety and tolerability will also be assessed.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Sporadic Superficial and Nodular Skin Basal Cell Carcinomas

Intervention

LDE225, Vehicle

Location

Novartis Investigative Site
Graz
Austria

Status

Recruiting

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:13-0400

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