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

Completed · Phase 1/Phase 2

Conditions studied: Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID: NCT00652080
Run by: BPGbio
People needed: 35
Starts: 2008-06-01
Expected to finish: 2010-01-01
Last updated by the study team: 2019-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

Burke Pharmaceuticals — Hot Springs, Arkansas, United States
Skin Surgery Medical Group, Inc. — San Diego, California, United States
Glazer Dermatology — Buffalo Grove, Illinois, United States
Long Island Skin Cancer and Dermatalogic Surgery, PC — Smithtown, New York, United States
Education and Research Foundation — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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