Clinical Research Directory

Key Inclusion Criteria: * area on each dorsal forearm with 4-12 clinically typical, discrete and visibly evident AK lesions within a 25-100 cm2 area * willing to comply with the study requirements, including refraining from use of medications or other treatments for the skin disease (including sun and ultraviolet light exposure), and is able to reliably apply topical medications Key Exclusion Criteria: * significant skin disease other than AK which may interfere with interpretation of clinical findings * atypical or rapidly changing AK lesions at the intended treatment and control area (including cutaneous horn, hyperkeratotic, hypertrophic lesions) * clinically relevant co-morbid medical conditions or findings on physical examination or in laboratory analyses * known or suspected pregnancy or lactation (female patients), or planned pregnancy (female and female partners of male patients) * treatment with 5-fluorouracil (5-FU), tirbanibulin, imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within the intended treatment and control area or within 2 inches (or 5 cm) of the treatment and control area, within 28 days prior to Screening and Day 1visit * treatment with cosmetic or therapeutic procedures (eg, use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing), use of acid-containing therapeutic products (eg, salicylic acid or fruit acids, such as alpha and beta-hydroxyl acids and glycolic acids), topical retinoids, light chemical peels, topical steroids, artificial tanners, or other topical medicinals (non-medicated and non-irritating lotions or creams are permitted) within the intended treatment and control area or within 2 inches (or 5 cm) of the treatment and control area, within 14 days prior to Screening and Day 1 visit * treatment with immunomodulators (eg, azathioprine), cytotoxic drugs (eg, cyclophosphamide, vinblastine, chlorambucil, methotrexate), interferons/interferon inducers, medications that suppress the immune system (eg, cyclosporine, prednisone, methotrexate, alefacept, infliximab) within 28 days prior to Screening and Day 1 visit * treatment with systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to Screening and Day 1 visit