Efficacy Study & Safety Evaluation of SR-T100 Gel in Actinic Keratosis Treatment

Inclusion Criteria:

Male or female is 20 years of age or above and patient has at least two clinically visible, discrete, non hyperkeratotic, hypertrophic AK lesions located within a 25 cm squared contiguous or non contiguous treatment area including the arms, shoulder, chest, face and scalp. Patient has at least one histological confirmed actinic keratosis lesion of greater or equal to 4 mm in diameter within the selected treatment area.

Exclusion Criteria:

1. Patient has any dermatological disease and condition, such as atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, melanoma, or other possible confounding skin conditions in the treatment or surrounding area within 5cm distances from treatment area.
2. Patient had used the following treatments within 4 weeks prior to the study treatment initiation as immunomodulators or immunosuppressive therapy,interferon and cytotoxic drugs.
3. Patient treated with topical 5 FU, diclofenac gel, imiquimod, corticosteroids, retinoids, masoprocol on the treatment area within 4 weeks prior to the study treatment initiation.
4. Patient received cryodestruction, chemodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks prior to the study treatment initiation.
5. Patient had received any of the following treatments on the treatment area in 6 months before study treatment initiation begins, such as psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion chemical peel.
6. Patient is known to be hypersensitive to the study medication.
7. Female who is pregnant, breast fed or considers of becoming pregnant while on the study.
8. Patient had used of any investigational drug within the past 30 days before enrollment.