A Double-blind, Randomized, Vehicle-controlled, Parallel-group, Phase II Dose-ranging Study to Evaluate the Efficacy and Safety of SR-T100 Gel in Patients With Actinic Keratosis (AK) on the Head (Face and/or Scalp)
1. Male or female; aged ≥ 18 years old.
2. Patient who accepts to enter the study by signing written informed consent.
3. Patient has 4 to 8 clinically diagnosed, discrete, non-hyperkeratotic,
non-hypertrophic AK, located with or without a contiguous 25cm2 areas on the face
and/or balding scalp.
4. Patient allows biopsy to be performed on selected lesion.
5. Patient agrees to apply the study medication on prescribed treatment area with an
occlusive dressing at least 20 hours per day.
6. Patient agrees photographs to be taken on selected lesion and used as part of the
study data package.
7. Patient in good general health condition (performance status ≤ 2 Eastern Cooperative
Oncology Group (ECOG).
8. Female patient with child-bearing potential must take reliable contraception
method(s) during the participation of the study.
1. Patient with recurrent invasive squamous cell carcinoma (SCC).
2. Patient has grossly suspicious or inflamed lymph nodes on physical examination.
3. Patient has evidence of clinically significant or unstable medical conditions.
4. Patient has any skin condition in the treatment area that may be made worse by
5. 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.
6. 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.
7. 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
8. Engaging in activities involving excessive or prolonged exposure to sunlight.
9. History of allergy or sensitivity to related compounds or other components of the
investigational product formulation.
10. Woman who is pregnant, lactating or planning to become pregnant during the study.
11. Patient used any investigational drug within 8 weeks prior to the screening visit.