Effect of a Photolyase-Based Medical Device on Actinic Keratosis in Phototypes III-IV Patients: Real-Life Clinical Setting.

Introduction: Actinic keratoses (AK) are premalignant skin lesions that occur in chronically photo-exposed body areas. Topical sunscreens prevent but do not reverse ultraviolet radiation (UVR)-induced damage to deoxyribonucleic acid (DNA). Eryfotona is a sunscreen product that combines high solar protection factors with light-driven DNA repair enzymes known as photolyases. This photolyase-based medical device has been shown to reduce the absolute number of AK; however, a more comprehensive assessment of AK lesions is ideal for determining its actual effect in everyday practice. The purpose of the study is to evaluate the photoprotective effect of Eryfotona sunscreen on individual AK lesions, assessing changes in their clinical and dermoscopic presentation in a real-life clinical setting and the impact on the health-related quality of life.

Methods: This was an observational, prospective, real-life study of adult patients with skin phototypes III or IV and actinic keratosis (AK) lesions on the face and scalp. Patients were treated with sunscreen containing photolyase twice daily for 6 months, with follow-up visits at 3 and 6 months. The clinical evaluation included the actinic keratosis and severity index (AKASI), the absolute number and individual dimensions of AK lesions, and the Olsen clinical classification scheme. The dermoscopic evaluation included the Zalaudek classification and assessment of lesion pigmentation. The AK Quality of Life (AKQoL) questionnaire was administered to patients during each follow-up. A repeated measures analysis of variance was performed to compare quantitative outcomes, and Fisher's exact tests were used for categorical variables.

Results: A total of 45 patients with 205 AK lesions were included; 25 patients completed both follow-ups. Clinically, there was a significant improvement from an AKASI score of 2.55 at baseline to 1.90 at 6 months (p = 0.000), and a significant difference was also observed in the dimensions of individual AK lesions and the Olsen classification between the three evaluation times (p = 0.000). Dermoscopic assessment, as classified by the Zalaudek classification, showed significant improvement throughout the three evaluations (p = 0.000). In total, 53 lesions disappeared, corresponding to 26.36% of the lesions.

Conclusions: Eryfotona provided effective and safe photoprotection and treatment of actinic keratosis on the face and scalp in patients with phototypes III and IV in the real-life clinical setting, showing promising effects on higher-grade lesions.