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

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