Evaluate RLS-1496 Topical Cream for Actinic Keratosis

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