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

February 14, 2025 updated by: BPGbio
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Burke Pharmaceuticals
    • California
      • San Diego, California, United States, 92108
        • Skin Surgery Medical Group, Inc.
    • Colorado
      • Denver, Colorado, United States, 80210
        • Colorado Medical Research Center
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Dermatology Associates and Research
    • Georgia
      • Snellville, Georgia, United States, 30078
        • Gwinnett Clinical Research
    • Illinois
      • Buffalo Grove, Illinois, United States, 60089
        • Scott D. Glazer, M.D., S.C.
      • Champaign, Illinois, United States, 61820
        • Christie Clinic
    • New York
      • Smithtown, New York, United States, 11787
        • Long Island Skin Cancer and Dermatologic Surgery, PC
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Dermatology and Research Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Dermatology Clinical Research Center of San Antonio
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Education & Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female adults ≥ 18 years of age
  • Primary, histologically confirmed sBCC with a minimum area of 0.5 cm2 and with a maximum diameter of 2.0 cm target sBCC lesion suitable for excision
  • Histological diagnosis made no more than 4 weeks prior to the screening visit
  • Histological biopsy removed 25% or less of the target lesion
  • No other dermatological disease in the sBCC target site or surrounding area
  • Willing to refrain from using non-approved lotions or creams on the target site and surrounding area during the treatment period. Willing to refrain from washing the treated area for at least 8 hours following the application of study medication
  • Willing to refrain from exposure to direct sunlight or ultraviolet light and to avoid the use of tanning parlors for the duration of the study
  • Laboratory values for the tests listed in the Study Schedule on page 2 within the reference ranges as defined by the central laboratory, or "out of range" test results that are clinically acceptable to the investigator.
  • Ability to follow study instructions and likely to complete all study requirements
  • Written informed consent obtained, including consent for tissue to be examined and stored by the central dermatopathologist
  • Written consent to allow photographs of the target sBCC lesion to be used as part of the study data
  • For females of childbearing potential, a negative pregnancy test at screening and using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom, diaphragm, abstinence, or a monogamous relationship with a partner who has had a vasectomy)

Exclusion Criteria:

  • Pregnant or lactating
  • Presence of known or suspected systemic cancer
  • Histological evidence of nBCC, SCC, or any other tumor in the biopsy specimen
  • Histological evidence of severe squamous metaplasia, infiltrative, desomoplastic or micronodular growth patterns in the biopsy specimen
  • History of recurrence of the target sBCC lesion
  • Evidence of dermatological disease or confounding skin condition in the treatment area, e.g., SCC, actinic keratosis, rosacea, psoriasis, atopic dermatitis, eczema, xeroderma pigmentosa
  • Concurrent disease or treatment that suppresses the immune system
  • Chronic medical condition that in the judgment of the investigator(s) would interfere with the performance of the study or would place the patient at undue risk
  • Known sensitivity to any of the ingredients in the study medication
  • Use of a tanning parlor or other excessive or prolonged exposure to ultraviolet light or direct sunlight during the course of the study
  • Treatment with systemic chemotherapeutic agents within the 6 months prior to the screening visit
  • Use of systemic retinoids within the 6 months prior to the screening period
  • Treatment with systemic immunomodulators or immunosuppressants within the 6 months prior to the screening period
  • Use of topical immunomodulators within 2 cm of the target BCC lesion within the 4 weeks prior to the screening period
  • Treatment with the following topical agents within the 4 weeks prior to the screening visit: levulanic acid, 5-fluorouracil, coricosteroids, retinoids, diclofenac, hyaluronic acid, imiquimod
  • Undergone a facial resurfacing procedure, i.e., chemical peel, laser resurfacing, dermabrasion, within the 6 months prior to the screening visit, if the target sBCC lesion is on the face
  • Treatment with liquid nitrogen, surgical excision or curettage within 2 cm of the target sBCC lesion during the 4 weeks prior to the screening visit
  • Elective surgery within 4 weeks prior to the screening visit, during the study, or 4 weeks after the treatment period
  • Evidence of current chronic alcohol or drug abuse
  • Current enrollment in an investigational drug or device study or participation in such a study within 4 weeks of the screening visit
  • In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions of the protocol and complete the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Active cream, 3% AM & PM
Drug: API 31510 3% Topical Cream
Topical treatment 3% active cream applied to the lesion
Placebo Comparator: 2
Placebo cream AM ; 3% active cream PM
Drug: API 31510 3% Topical Cream
Topical treatment 3% active cream applied to the lesion
Other: Placebo
Topical treatment placebo applied to the lesion
Placebo Comparator: 3
Placebo cream AM; 1.5% active cream PM
Other: Placebo
Topical treatment placebo applied to the lesion
Drug: API 31510 1.5% Topical Cream
Topical treatment 1.5% active cream applied to the lesion
Placebo Comparator: 4
Placebo AM and PM
Other: Placebo
Topical treatment placebo applied to the lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Complete Response
Time Frame: 10 weeks
To determine the number of participants with a complete response, defined as a negative histological examination of the sBCC lesion at Week 10 (4 weeks post-treatment).
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Partial Response
Time Frame: 10 weeks
To determine the number of participants with a partial response, defined as a clinically significant decrease (ie, at least 50%) in the area of the sBCC lesion, computed as the product of the two principal diameters at Week 10 (4 weeks post-treatment)
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BPGbio

Investigators

  • Principal Investigator: David Wilson, MD, Education and Research Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

January 17, 2008

First Submitted That Met QC Criteria

January 17, 2008

First Posted (Estimated)

January 30, 2008

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTL0108

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe