Clinical study experience with diclofenac gel for actinic keratoses

Author:Anoma Ranaweera B.V. Sc; PhD (Clinical Biochemistry, University of Liverpool, UK). Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, July 2015.

The efficacy of 3% diclofenac hyaluronic acid (HA) gel (0.5 g applied twice daily to each 5 cm x 5 cm treatment area) in patients with actinic keratoses (AK) has been evaluated in at least 2 published randomised, double-blind, HA gel vehicle-controlled trials.

A multicenter, randomised, double-blind, placebo-controlled study treated 195 patients with diclofenac, 0.5 g or vehicle, twice daily for either 30 days or 60 days.

In a separate randomised, double-blind, placebo-controlled trial involving 117 evaluable patients, with >5 AK lesions, adult patients received either 3% diclofenac gel in 2.5% hyaluronan gel or the gel vehicle as a placebo. They received diclofenac 0.5 g twice daily for 90 days.

A prospective, double-arm, multicenter, open-label, phase IV study performed at 82 community dermatology centres in the US and involving 521 evaluable patients has shown that the sequential treatment with cryosurgery followed by diclofenac sodium 3% gel for 90 days is well tolerated and can provide a more successful outcome than monotherapy with cryosurgery.

A separate multicentre, randomized open-label study including 418 patients with mild to moderate AKs has investigated whether prolonged treatment with diclofenac in HA for 6 months adds to the efficacy in treatment for AK.

Active comparator studies have demonstrated comparable efficacy of diclofenac sodium 3% gel with 5% 5-fluorouracil cream and 5% imiquimod cream.

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