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

NCT00604890 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: CTL0108
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 11

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.

Conditions

Superficial Basal Cell Carcinoma

Keywords

Double-Blind; Placebo; Topical; Treatment; Dose-Ranging; sBCC

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Response

  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 Outcomes (1)

• Number of Participants With Partial Response

  10 weeks

Study Arms (4)

1

EXPERIMENTAL

Active cream, 3% AM \& PM

Drug: API 31510 3% Topical Cream

2

PLACEBO COMPARATOR

Placebo cream AM ; 3% active cream PM

Drug: API 31510 3% Topical Cream; Other: Placebo

3

PLACEBO COMPARATOR

Placebo cream AM; 1.5% active cream PM

Drug: API 31510 1.5% Topical Cream; Other: Placebo

4

PLACEBO COMPARATOR

Placebo AM and PM

Other: Placebo

Interventions

API 31510 3% Topical Cream DRUG

Topical treatment 3% active cream applied to the lesion

1; 2

API 31510 1.5% Topical Cream DRUG

Topical treatment 1.5% active cream applied to the lesion

3

Placebo OTHER

Topical treatment placebo applied to the lesion

2; 3; 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• BPGbio: lead

Study Sites (11)

Burke Pharmaceuticals

Hot Springs, Arkansas, 71913, United States

Location

Skin Surgery Medical Group, Inc.

San Diego, California, 92108, United States

Location

Colorado Medical Research Center

Denver, Colorado, 80210, United States

Location

Dermatology Associates and Research

Coral Gables, Florida, 33134, United States

Location

Gwinnett Clinical Research

Snellville, Georgia, 30078, United States

Location

Scott D. Glazer, M.D., S.C.

Buffalo Grove, Illinois, 60089, United States

Location

Christie Clinic

Champaign, Illinois, 61820, United States

Location

Long Island Skin Cancer and Dermatologic Surgery, PC

Smithtown, New York, 11787, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Education & Research Foundation

Lynchburg, Virginia, 24501, United States

Location

Results Point of Contact

• Title: Nathaniel DiTommaso
• Organization: Berg LLC

nate.ditommaso@berghealth.com

617-588-1002

Study Officials

• David Wilson, MD

  Education and Research Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: January 30, 2008
• Study Start: March 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 28, 2025
• Results First Posted: March 5, 2019

Record last verified: 2019-02

Locations

US (11)