Conditions: Sporadic Superficial and Nodular Skin Basal Cell Carcinomas
Keywords: Basal cell carcinomas, sporadic, superficial and nodular, skin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 25
Healthy volunteers: no

Brief summary:
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).

Detailed description:

Arms:
arm 1: Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks. arm 2: Participants topically applied matching placebo cream twice daily for 6 weeks.

Interventions: intervention 1: LDE225 0.75% intervention 2: Vehicle
Intervention descriptions: intervention 1: 0.75% cream intervention 2: matching placebo cream to 0.75% LDE225 cream

Protocol document: