Phase I/IIa Trial to Evaluate AVX001 Gel in Doses of 1% or 3% Compared With Vehicle Over Four Weeks of Field-directed Treatment Period in Adult Subjects With AK

Exclusion Criteria

• •1. AK lesions classified as Olsen grade 3 in target area
• •2. Atypical AK lesions in the target area, including suspected SCC or BCC
• •3. Under suspicion of, or current skin cancer diagnosis in the target area. subjects who had BCC, SCC or melanoma and have completed curative therapy at least 12 months prior to screening and are in remission can be considered to participate in the trial by investigator's discretion
• •4. Any dermatological condition in the target area that can be exacerbated by treatment or affect trial assessments, including but not limited to psoriasis vulgaris AD, rosacea, urticaria, scabies, and herpes simplex
• •5. Received immunosuppressive/immunomodulating drugs including but not limited to methotrexate, cyclosporine, azathioprine, oral retinoids, 6 months prior to baseline visit.
• •6. Received systemic corticosteroids including but not limited to betamethasone, prednisone, dexamethasone, methylprednisolone (except if via inhale or intranasal delivery) 6 months prior to baseline visit.
• •7. Received lesion or field directed therapy within 2 cm of the target area for trial treatment one month prior to baseline visit, including topical drugs, including but not limited to
• •* topical fluorouracil, imiquimod, ingenol mebutate and diclofenac.
• •* destructive therapies, including but not limited to surgery, cryotherapy, dermabrasion, and photodynamic therapy
• •* field ablation treatments, including but not limited to chemical peels, laser resurfacing
• •8. Recipient of organ transplant including but not limited to bone marrow, kidney, liver, heart
• •9. Any unstable neurological or psychiatric disorder based on the investigator's opinion which has the potential to affect the safety of the subject, influence on trial objectives or impede the subject's ability to complete the trial.
• •10. History of chronic alcohol or drug abuse within 12 months prior to screening or any condition associated with poor compliance at the investigator's discretion
• •11. Received treatment with any non-approved drug substance within the last 4 weeks prior to baseline visit.
• •12. Known allergy or intolerance to fish, shellfish or fish oil
• •13. Concurrent participation in any other clinical trial or participation in any clinical trial treatments 4 weeks prior to enrolment.
• •14. Subject is pregnant or lactating