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

Superficial Basal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604890
• Other study ID #: CTL0108
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2008
• Est. completion date: January 2010

Study information

• Verified date: February 2019
• Source: Berg, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell
• Superficial Basal Cell Carcinoma

Intervention

Drug:
• API 31510 3% Topical Cream
Topical treatment 3% active cream applied to the lesion
• 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

Locations

Country	Name	City	State
United States	Scott D. Glazer, M.D., S.C.	Buffalo Grove	Illinois
United States	Christie Clinic	Champaign	Illinois
United States	Dermatology Associates and Research	Coral Gables	Florida
United States	Colorado Medical Research Center	Denver	Colorado
United States	Burke Pharmaceuticals	Hot Springs	Arkansas
United States	Education & Research Foundation	Lynchburg	Virginia
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Skin Surgery Medical Group, Inc.	San Diego	California
United States	Long Island Skin Cancer and Dermatologic Surgery, PC	Smithtown	New York
United States	Gwinnett Clinical Research	Snellville	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Berg, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Partial Response	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