An Open-Label Safety Study of API 31510 in a Topical Cream for in Situ Cutaneous Squamous Cell Carcinoma (SCCIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Berg, LLC
ClinicalTrials.gov Identifier:
NCT00652080
First received: March 31, 2008
Last updated: July 24, 2012
Last verified: February 2010
  Purpose

The purpose of this study is to determine the safety and tolerability of pharmaceutical compound 31510 in a topical cream when applied to in situ cutaneous squamous cell carcinoma and to obtain preliminary efficacy data for the treatment of in situ cutaneous squamous cell carcinoma by Compound 31510 topical cream.


Condition Intervention Phase
Squamous Cell Carcinoma
Drug: API 31510
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Berg, LLC:

Primary Outcome Measures:
  • To determine the safety and tolerability of API 31510 cream 3%, topically applied to in situ cutaneous squamous cell carcinomas (SCCIS). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To obtain a preliminary determination of the efficacy of API 31510 cream 3%,topically applied to in situ cutaneous squamous cell carcinomas [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: June 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; 3% active; AM & PM application

  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 SCCIS with a minimum area of 0.5 cm2 and with a maximum diameter of 2.0 cm target SCCIS 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 SCCIS 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 SCCIS 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, sBCC, or any other tumor in the biopsy specimen
  • Histological evidence of severe squamous metaplasia, infiltrative, desmoplastic or micronodular growth patterns in the biopsy specimen
  • History of recurrence of the target SCCIS lesion
  • Evidence of dermatological disease or confounding skin condition in the treatment area, e.g., BCC, 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 SCCIS 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; levulinic acid, 5-fluorouracil, corticosteroids, 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 SCCIS lesion is on the face
  • Treatment with liquid nitrogen, surgical excision or curettage within 2cm of the target SCCIS 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652080

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, 92117
United States, Illinois
Glazer Dermatology
Buffalo Grove, Illinois, United States, 60089
United States, New York
Long Island Skin Cancer and Dermatalogic Surgery, PC
Smithtown, New York, United States, 11787
United States, Virginia
Education and Research Foundation
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
Berg, LLC
  More Information

No publications provided

Responsible Party: Berg, LLC
ClinicalTrials.gov Identifier: NCT00652080     History of Changes
Other Study ID Numbers: CTL0408
Study First Received: March 31, 2008
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 20, 2014