Conditions: Superficial Basal Cell Carcinoma
Keywords: Double-Blind Placebo Topical Treatment Dose-Ranging sBCC
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 186
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the safety and tolerability of pharmaceutical compound (API 31510) topical cream topically applied to superficial basal cell carcinomas to obtain preliminary efficacy data for the treatment of superficial basal cell carcinomas by API 31510 topical cream. The study population will include one hundred and sixty (160) otherwise healthy male or female adults with one or more histologically confirmed superficial basal cell carcinoma lesions. One target lesion with an area of less than one inch will be designated for study treatment.

Detailed description:

Arms:
arm 1: Active cream, 3% AM \& PM arm 2: Placebo cream AM ; 3% active cream PM arm 3: Placebo cream AM; 1.5% active cream PM arm 4: Placebo AM and PM

Interventions: intervention 1: API 31510 3% Topical Cream intervention 2: API 31510 1.5% Topical Cream intervention 3: Placebo
Intervention descriptions: intervention 1: Topical treatment 3% active cream applied to the lesion intervention 2: Topical treatment 1.5% active cream applied to the lesion intervention 3: Topical treatment placebo applied to the lesion

Protocol document: