A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis

Exclusion Criteria

• •1. Active gastrointestinal ulceration or bleeding.
• •2. Current or history of severe renal or hepatic impairment.
• •3. Presence of atopic dermatitis, basal cell carcinoma, squamous cell carcinoma, eczema, psoriasis, rosacea, sunburn or other possible skin conditions on the face or bald scalp that in the investigator's opinion would interfere with the study assessments.
• •4. Use within six months prior to randomization of oral isotretinoin.
• •5. Use within six months prior to randomization on the face or bald scalp of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA (psoralen plus ultraviolet A) therapy, or 5) UVB therapy
• •6. Use within one month prior to randomization on the face or bald scalp of 1) cryodestruction or chemodestruction, 2)curettage, 3) photodynamic therapy, 4) surgical excision, 5)topical 5-fluorouracil, 6) topical corticosteroids, 7) topical diclofenac, 8) topical Imiquimod, 9) topical retinoids, or 10) other treatments for actinic keratosis including glycolic acids or over-the-counter products containing retinol, alpha or beta hydroxy acids.
• •7. Use within one month prior to randomization of 1)immunomodulators or immunosuppressive therapies, 2)interferon, 3) systemic corticosteroids or 4) cytotoxic drugs. (The occasional use of ophthalmic, nasal or inhaled steroids is acceptable and not reason for exclusion)
• •8. Known allergies to diclofenac sodium, benzyl alcohol, polyethylene glycol monomethyl ether 359, hyaluronate sodium or any excipients in the test or reference gels.
• •9. Receiving 5-Fluorouracil or other systemic cancer chemotherapy within 6 months prior to randomization.
• •10. Any condition, medical, psychological, or social, that, in the Investigator's opinion, would interfere with participation in the study.
• •11. Women who are pregnant, planning pregnancy or lactating.
• •12. Participation in any investigational drug study within 30 days of randomization or previous participation in this study.
• •13. Employees of the research center or Investigator.
• •14. Family members of employees of the research center or Investigator.