Comparison of the Efficacy of Cryotherapy and 0.1 % Acnalen Gel vs. Cryotherapy and Placebo in the Treatment of Actinic Keratoses

Actinic keratoses (AKs) caused by chronic UV radiations have the potential to progress to squamous cell carcinoma (SCC). Cryotherapy is the most frequently employed method focused on lesions; however it is not useful for treatment of early or subclinical AKs. Therefore, combination therapy with topical agents may be more efficient. The aim of this study was to compare efficacy of cryotherapy and acnalen gel 0.1% (a topical retinoid) with cryotherapy and placebo in the treatment of AKs. In a randomized, double-blind, placebo-controlled trial, 112 outpatients with clinical diagnosis of AKs on face or scalp with at least 5 lesions were enrolled. The patients were randomized into two groups: cryotherapy and placebo or cryotherapy and acnalen 0.1% gel for a period of 100 days. Lesion counts were assessed at baseline, 40, 70 and 100 days after cryotherapy. One hundred patients with the mean number of 7.54±3.66 lesions for treatment group and 7.20±3.60 lesions for placebo group at baseline completed the study. In acnalen group the mean number of lesions reduced to 3.44±2.71 (mean reduction: 54.79 ± 3.8 %) at day 100, while in placebo group it reduced to 3.68±2.97 (mean reduction: 48.60±4.5 %). This difference was not statistically significant (P=0.62). Adverse events were not significantly different between the groups. Cryotherapy and acnalen 0.1% gel during 100 days cannot be more helpful than cryotherapy alone in the treatment of clinical AKs.