Therapeutic Equivalence of Diclofenac Sodium Gel 3% vs Solaraze ® in the Treatment of Actinic Keratosis

Exclusion Criteria

• •1. Females who are pregnant, lactating or planning to become pregnant during the study period.
• •2. Active gastrointestinal ulceration or bleeding.
• •3. Current evidence or history of severe renal or hepatic impairment.
• •4. Known allergy or hypersensitivity to diclofenac, benzyl alcohol, polyethylene glycol monomethyl ether 359, hyaluronate sodium or other excipients in the test, reference or vehicle gel.
• •5. Known allergy or hypersensitivity to other NSAIDs, including aspirin.
• •6. Presence of atopic dermatitis, basal cell carcinoma, squamous cell carcinoma, eczema, psoriasis, rosacea, sunburn, exfoliative dermatitis, open or recent skin wounds, active infections or other possible skin conditions on the face or bald scalp that in the Investigator's opinion would interfere with the study assessments or put the patient at risk.
• •7. Use of oral isotretinoin within six months before randomization.
• •8. Use within six months before Visit 1 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.
• •9. Use within one month before Visit 1 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 AK including glycolic acids or over the- counter (OTC) products containing retinol, alpha or beta hydroxy acids. The occasional use of ophthalmic, intranasal or inhaled corticosteroids (e.g., management of allergic conjunctivitis) is acceptable and not reason for exclusion. Use of inhaled corticosteroids for the management of chronic and stable conditions (e.g., persistent asthma and chronic obstructive pulmonary disease \[COPD\]) is acceptable as long as it has been on a stable dose for a minimum of three months before the start of the study and up to 1 mg/day.
• •10. Use within one month before Visit 1 of 1) immunomodulators or immunosuppressive therapies, 2) interferon, 3) systemic corticosteroids or 4) cytotoxic drugs.
• •11. Receipt of 5-Fluorouracil or other systemic cancer chemotherapy within 6 months before Visit 1.
• •12. Any condition, medical, psychological, or social, that, in the Investigator's opinion, would interfere with participation in the study or put the patient at risk.
• •13. Inability to understand the requirements of the study and the relative information or are unable or not willing to comply with the study protocol.
• •14. Receipt of any drug as part of a research study within 30 days before Visit 1.
• •15. Employees of the Investigator or research center or their immediate family members.
• •16. Patients who have participated in this study previously.