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

NCT00604890 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2025-02-28

Study results available
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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

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

Sponsors & Collaborators

  • BPGbio

    lead INDUSTRY

Principal Investigators

  • David Wilson, MD · Education and Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-01-31
Completion
2010-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00604890 on ClinicalTrials.gov