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An Open Study to Assess the Efficacy and Safety of Topical 3% Diclofenac in a 2.5% Hyaluronic Acid Gel for the Treatment of Actinic Keratoses

Jason K. Rivers, MD, FRCPC; David I. McLean, MD, FRCPC
Arch Dermatol. 1997;133(10):1239-1242. doi:10.1001/archderm.1997.03890460061007.
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Background:  Actinic keratoses are potential precursors of invasive squamous cell carcinoma; therefore, treatment is often recommended. Current topical treatments may cause considerable discomfort, pain, or skin irritation. This study was established to explore the role, if any, of topical 3% diclofenac in 2.5% hyaluronic acid gel in the management of actinic keratoses.

Observations:  An open-label study was conducted of topical 3% diclofenac in 2.5% hyaluronic acid gel applied to 1 or more actinic keratoses. Patients were instructed to apply 1.0 g of the gel twice daily for as many as 180 days. Treatment was stopped earlier than 180 days if lesions were assessed as cleared. Twenty-nine adults were treated for periods of 33 to 176 days (median, 62 days). Of the 29 subjects, 27 were reevaluated 30 days after drug therapy discontinuation. Of the 27 patients, 22 (81%) had a complete response and another 4 (15%) showed marked clinical improvement. The preparation was generally well tolerated, although in 7 patients (24%) an irritant-type contact dermatitis developed, which was confined to the treatment site.

Conclusion:  Topical 3% diclofenac in 2.5% hyaluronic acid gel may be a clinically useful topical agent for the treatment of actinic keratoses.Arch Dermatol. 1997;133:1239-1242

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