J Drugs Dermatol
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Multicenter Study Clinical Trial
Phase IV, open-label assessment of the treatment of actinic keratosis with 3.0% diclofenac sodium topical gel (Solaraze).
A clearance rate of all occurrences > or = 75% for actinic keratoses (AK) lesions is an accepted efficacy endpoint for topical agents. This efficacy endpoint has not been assessed for 3.0% diclofenac sodium gel (Solaraze). We evaluated the efficacy and tolerability of 3.0% diclofenac sodium gel in the treatment of AK for a treatment period of 90 days and a 30-day follow-up period. ⋯ A total of 39 patients (51%) experienced at least 1 adverse event considered to be related to 3.0% diclofenac sodium gel during the study. Dry skin and rash at the application site were most common reported adverse events, and most of these adverse events were mild or moderate in severity. The topical application of 3.0% diclofenac sodium gel provides a safe and effective approach for the treatment of AK.