Trial Information
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
Inclusion Criteria:
- Patients with one histologically confirmed superficial and nodular basal cell
carcinoma (8-20 mm) eligible for surgical excision on selected body areas (scalp,
arm, frontal trunk, posterior trunk, upper legs)
Exclusion Criteria:
- Previous treatment of the sBCC that are selected for treatment.
- Any systemic treatment which is known to affect BCCs esp. cytostatic treatments,
retinoids and photodynamic treatments.
- Dark-skinned persons whose skin color prevents readily assessment of skin reactions
Other protocol defined Incl./Excl. criteria may apply.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Clinical evaluation of sBCCs tumors (complete response, partial response, no response / worsening)
Outcome Time Frame:
12 weeks
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Austria: Federal Office for Safety in Health Care
Study ID:
CLDE225B2204
NCT ID:
NCT01033019
Start Date:
December 2009
Completion Date:
Related Keywords:
- Sporadic Superficial and Nodular Skin Basal Cell Carcinomas
- Basal cell carcinomas,
- sporadic,
- superficial and nodular,
- skin
- Carcinoma
- Carcinoma, Basal Cell