Efficacy and Safety Phase II Study of SR-T100 to Treat Actinic Keratosis

Inclusion criteria

• Male or female; aged ≥ 18 years old.
• Patient who accepts to enter the study by signing written informed consent.
• Patient has 4 to 8 clinically diagnosed, discrete, non-hyperkeratotic, non-hypertrophic AK, located with or without a contiguous 25cm2 areas.
• Patient allows biopsy to be performed on selected lesion.
• Patient agrees to apply the study medication on prescribed treatment area with an occlusive dressing at least 20 hours per day.
• Patient agrees photographs to be taken on selected lesion and used as part of the study data package.
• Patient in good general health condition (performance status ≤ 2 Eastern Cooperative Oncology Group (ECOG).
• Sexually active female patient with child-bearing potential must take reliable contraception method(s) during the participation of the study.

Exclusion criteria

• Patient with recurrent invasive squamous cell carcinoma (SCC).
• Patient has grossly suspicious or inflamed lymph nodes on physical examination.
• Patient has evidence of clinically significant or unstable medical conditions.
• Patient has any skin condition in the treatment area that may be made worse by treatment.
• Patient currently uses or had used on the treatment area(s) OTC retinol products, corticosteroids, cryosurgery, curettage, 5-fluorouracil (5-FU), imiquimod, topical diclofenac, retinoids, or other topical AK treatments (such as laser abrasion, dermabrasion, glycolic acids, or chemical peels) 28 days prior to screening visit.
• Patient had received systemic cancer chemotherapy or immunosuppressant; on the target evaluation area that psoralen plus UVA therapy, UVB therapy were treated 6 months prior to screening visit.
• Patient currently uses or has used prednisone and/or prednisolone (≥ 10 mg or the equivalent) more than 2 weeks continuously within 12 weeks prior to randomization visit.
• Engaging in activities involving excessive or prolonged exposure to sunlight.
• History of allergy or sensitivity to related compounds or other components of the investigational product formulation.
• Woman who is pregnant, lactating or planning to become pregnant during the study.
• Patient used any investigational drug within 8 weeks prior to the screening visit.