Evaluation of a Topical Treatment for Actinic Keratosis

Phase 2 Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study

A topical treatment applied twice daily for 4 weeks to induce disappearance of facial actinic keratosis (AK). First 4 weeks treatment (visit 1, 2 and 3 at 0,2 an 4 weeks) treated as a double blind parallel study. From weeks 4 to 7 (visit 3 to visit 4) all patients to be treated by the active component.

Inclusion Criteria:

• Males or females 30 to 90 years old, inclusive, in good general health
• Clinical diagnosis of Actinic Keratosis
• At least 2 clinically diagnosed, 3-15 mm AK lesions on face or scalp
• Patient is competent to understand and sign a consent form, and is willing and able to follow study procedures and attend all visits
• Female patients of childbearing potential must have a negative urine pregnancy test prior to receiving study medication
• Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception
• Pharmacologic methods of contraception should be stable for 1 month prior to Visit 1 and be maintained at same dose during the study

Exclusion Criteria:

• Patients who had been treated with: 5-FU, diclofenac, retinoids, ingenol mebutate or imiquimod within 4 weeks of study, immunomodulators, or interferon/interferon inducers or systemic immunosuppressants within 8 weeks of study, cryodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks of study, systemic cancer therapy, UVA therapy, UVB therapy, laser abrasion, dermabrasion
• History of hereditary angio-edema, Epilepsy or Parkinson's Disease
• Erythroderma or history of immunodeficiency disorders
• Pregnancy, lactation or patient who is not practicing effective contraception
• History of alcohol and drug abuse within 5 years of screening
• Known hypersensitivity or previous allergic reaction to any of the components of the study medication
• Having a member of the same household in the trial
• Patient has participated in an investigational clinical, surgical, drug or device study within the past 30 days
• Patients who in the opinion of the investigator should not be included in the study for any reason, including inability to follow procedures