Efficacy of 3% Diclofenac Gel for the Treatment of Actinic Keratoses: A Randomized, Double-Blind, Placebo Controlled Study Publisher Pubmed



Fariba I^{1, 4} ; Ali A² ; Hossein S³ ; Atefeh S¹ ; Afshin AZBS¹ Show Affiliations
Source: Indian Journal of Dermatology, Venereology and Leprology Published:2006

Abstract

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.; Indications:20 patients with actinic keratosis (scalp or face).; Patients:20 patients, men and women aged between 30 and 75 years, mean age 55.1 years, treated as outpatients. Duration of follow up was 90 days.; TypeofStudy:Efficacy of Voltaren gel was investigated in patients with actinic keratoses. Randomized, double-blind, placebo-controlled study.; DosageDuration:Dose not stated (0.5 g of 3% gel per treatment area of 5 cm2, applied topically bid). Duration: 90 days.; AuthorsConclusions:We conclude that 3% diclofenac in 2.5% hyaluronan gel is safe, but only somewhat effective for the treatment of actinic keratosis. It may be useful for patients who do not tolerate other, more effective kinds of treatment for actinic keratosis.; Results:Size of lesions treated with placebo fell from mean 0.59 to 0.56 cm2 (8.47% decrease, p=0.044 vs. baseline) and size of lesions treated with Voltaren fell from mean 0.66 to 0.39 cm2 (40.9% decrease, p<0.0005 vs. baseline); difference between groups was significant at study endpoint (p<0.0005). Among 32 lesions treated with placebo, 3.1% completely resolved, 34.3% were reduced, 59.5% were unchanged and 3.1% worsened; among 32 lesions treated with Voltaren, 9.3% completely resolved, 64.7% were reduced, 22.9% were unchanged and 3.1% worsened (difference between groups significant, p=0.001).; AdverseEffects:8 patients had skin irritation. No patient stopped therapy.; FreeText:Overall, 64 lesions in 20 patients were treated; 32 lesions were treated with Voltaren and the other 32 lesions (on the other side of the body) were treated with placebo (2.5% hyaluronan gel). Patients were advised to use sunscreen and to avoid excessive sun exposure. Additional therapy: sunscreen. Test: lesion size.