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
- 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)
- 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:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Clinical evaluation of sBCCs tumors (complete response, partial response, no response / worsening)
Outcome Time Frame:
Austria: Federal Office for Safety in Health Care
- Sporadic Superficial and Nodular Skin Basal Cell Carcinomas
- Basal cell carcinomas,
- superficial and nodular,
- Carcinoma, Basal Cell