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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Berg, LLC
ClinicalTrials.gov Identifier:
NCT00604890
First received: January 17, 2008
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Superficial Basal Cell Carcinoma
Drug: API 31510 Topical Cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose-Ranging Clinical Trial of Topical Creams Containing API 31510 for the Treatment of Superficial Basal Cell Carcinoma

Further study details as provided by Berg, LLC:

Primary Outcome Measures:
  • Primary Efficacy Endpoint: Complete response rate defined as the proportion of patients with clinical and histological clearance of the sBCC lesion at 4 weeks post-treatment (study week 10). [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary Efficacy Endpoint: Partial response rate of the sBCC lesion at 4 weeks post-treatment (study week 10) and blood levels of API 31510. [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 186
Study Start Date: March 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Active cream, 3% AM & PM
Drug: API 31510 Topical Cream
Topical treatment to lesion twice daily of randomized treatments that include 1.5% active cream, 3% active cream or placebo cream
Placebo Comparator: 2
Placebo cream AM ; 3% active cream PM
Drug: API 31510 Topical Cream
Topical treatment to lesion twice daily of randomized treatments that include 1.5% active cream, 3% active cream or placebo cream
Placebo Comparator: 3
Placebo cream AM; 1.5% active cream PM
Drug: API 31510 Topical Cream
Topical treatment to lesion twice daily of randomized treatments that include 1.5% active cream, 3% active cream or placebo cream
Placebo Comparator: 4
Placebo AM and PM
Drug: API 31510 Topical Cream
Topical treatment to lesion twice daily of randomized treatments that include 1.5% active cream, 3% active cream or placebo cream

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604890

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

No publications provided

Responsible Party: Berg, LLC
ClinicalTrials.gov Identifier: NCT00604890     History of Changes
Other Study ID Numbers: CTL0108
Study First Received: January 17, 2008
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Berg, LLC:
Double-Blind
Placebo
Topical
Treatment
Dose-Ranging
sBCC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on August 18, 2014