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

January 17, 2008
July 24, 2012
March 2008
January 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00604890 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Dose-Ranging Clinical Trial of Topical Creams Containing API 31510 for the Treatment of Superficial Basal Cell Carcinoma
Dose-Ranging Clinical Trial of Topical Creams Containing API 31510 for the Treatment of Superficial Basal Cell Carcinoma

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Superficial Basal Cell Carcinoma
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
  • Experimental: 1
    Active cream, 3% AM & PM
    Intervention: Drug: API 31510 Topical Cream
  • Placebo Comparator: 2
    Placebo cream AM ; 3% active cream PM
    Intervention: Drug: API 31510 Topical Cream
  • Placebo Comparator: 3
    Placebo cream AM; 1.5% active cream PM
    Intervention: Drug: API 31510 Topical Cream
  • Placebo Comparator: 4
    Placebo AM and PM
    Intervention: Drug: API 31510 Topical Cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
186
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00604890
CTL0108
Yes
Berg, LLC
Berg, LLC
Not Provided
Principal Investigator: David Wilson, MD Education and Research Foundation
Berg, LLC
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP