Status:
COMPLETED
An Open-Label Safety Study of API 31510 in a Topical Cream for in Situ Cutaneous Squamous Cell Carcinoma (SCCIS)
Lead Sponsor:
BPGbio
Conditions:
Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 prelim...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00652080
Start Date
June 1 2008
End Date
January 1 2010
Last Update
March 5 2019
Active Locations (5)
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1
Burke Pharmaceuticals
Hot Springs, Arkansas, United States, 71913
2
Skin Surgery Medical Group, Inc.
San Diego, California, United States, 92117
3
Glazer Dermatology
Buffalo Grove, Illinois, United States, 60089
4
Long Island Skin Cancer and Dermatalogic Surgery, PC
Smithtown, New York, United States, 11787