NCT00604890

Dose-Ranging Clinical Trial of Topical Creams Containing API 31510 for the Treatment of Superficial Basal Cell Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: BPGbio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Superficial Basal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	API 31510 3% Topical Cream	Topical treatment 3% active cream applied to the lesion
DRUG	API 31510 1.5% Topical Cream	Topical treatment 1.5% active cream applied to the lesion
OTHER	Placebo	Topical treatment placebo applied to the lesion

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-01-30
• Last updated: 2025-02-28
• Results posted: 2019-03-05

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study