Efficacy of new class I medical device for actinic keratoses: a randomized controlled prospective study

Background: The presence of Actinic Keratoses (AKs) represent the most important warning sign of subclinical ultraviolet radiation. Currently, the regular use of sunscreens is considered essential for the prevention of the development of AKs. Aim: We evaluated the effectiveness of a new class I Medical Device (MD) for the prevention and treatment of AKs vs traditional sunscreen alone (SPF 100+). Methods: We conducted a randomized controlled prospective study in 90 Caucasian patients: 62 immunocompetent and 28 Organ Transplant Recipients (OTRs). We randomly assigned subjects to the MD group or sunscreen alone in a 1:1 assignment ratio. The patients have been reevaluated after three and six months. Results: In immunocompetent patients treated with MD, at the end of the study the reduction of the mean number of AKs was 54.7 vs. 9.43% with photoprotector. In OTRs, the global reduction was of 36.7% after MD use compared to 14.3% with the sunscreen. The prevalence of NMSCs, in the patients treated with MD, was 11.11 and 17.18 with sunscreen; the incidence was 19.7 in patients treated with MD and 32.1 in those treated with sunscreen. Conclusion: The MD has demonstrated good efficacy in the reduction of visible AKs, encouraging its use also in high-risk category, like OTRs.