Efficacy of 3% diclofenac gel for the treatment of actinic keratoses: a randomized, double-blind, placebo controlled study.

BACKGROUND: Actinic keratoses (AKs) are premalignant skin lesions caused by excessive sun exposure. AIMS: To explore the therapeutic efficacy of 3% diclofenac in 2.5% hyaluronan gel in the topical treatment of AK. METHODS: Sixty-four lesions in 20 patients were evaluated. They were randomized to receive either the active treatment, 3% diclofenac in 2.5% hyaluronan gel or placebo, which consisted of the inactive gel vehicle, hyaluronan for a period of three months. The collected data were analyzed by using Student t- tests. RESULTS: There was a reduction in the lesion size in 64.7% of diclofenac-treated lesions and 34.3% of control lesions during the three-month course of treatment. Only 9.3% of the lesions in the diclofenac group were completely cleared during three months of treatment. During the treatment, no significant side-effect was observed in both groups. CONCLUSION: Considering the malignant potential of actinic keratoses and the importance of clearing them to prevent their transformation to squamous cell carcinoma, the efficacy of diclofenac gel seen in our study seems to be low. This treatment may be useful for patients who do not tolerate other, more effective kinds of treatment for actinic keratoses.