Zeitschrift für klinische und experimentelle Dermatologieforschung
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Abstrakt

A Pilot, Prospective, Open-Label Study on the Effects of a Topical Photorepair and Photoprotection Film-Forming Medical Device in Patients with Actinic Keratoses Evaluated by Means of Skin Analysis Camera Antera 3D

Mario Puviani and Massimo Milani

Background: Actinic keratosis (AK) is a very common precancerous skin lesion caused by chronic exposure to sunlight. UVA and UVB rays’ exposure is considered as the main pathogenic mechanism of keratinocytes alterations and malignant transformations. UVB and UVA cause direct alterations of DNA molecules, such as the formation of cyclobutane-pyrimidine dimers (CPD) and cellular structures damage, in particular membranes, trough free radicals formation. Eryfotona AK-NMSC (Ery) is a film-forming medical device (MD) class II indicated for the prevention and treatment of cancerization field in subjects with AK or non-melanoma skin cancers (NMSC). Ery is characterized by a photorepair action, thanks to its content in photolyase, an enzyme able repairing DNA CPD, and by high broadspectrum photoprotection (SPF 100+) (Repairsome). Controlled clinical studies have shown that this MD, both in the short and the long term, is able to induce in AK patients sub-clinical and clinical improvements at the cancerization field level.

Study aim: In this pilot, prospective study, we evaluated the effects of 3-month application of this product in 11 subjects with AK through an objective assessment by skin camera ANTERA 3D instrument. The primary endpoints of the study were to evaluate: a) the evolution of the skin haemoglobin content (parameter related to the level of “vascularization” and "inflammation" of the skin lesions) at the level of a target AK lesion, identified and defined at baseline visit and b) the evolution of AK lesion area.

Results: Ery treatment induced a statistically significant and clinically relevant reduction of AK target lesion area (a -75% reduction in comparison with baseline, range: -100%- 50%) and a significant haemoglobin content reduction as soon as after 1 month (-16%, p=0.01) and after 3 months of treatment (-34%, p=0.01) demonstrating an effect of "normalization" of this parameter at the AK target lesion level. The product was well tolerated.

Conclusion: Data from this pilot study suggest that the use of a photorepair and photoprotection film-forming MD in subjects with AK is able to change in the short-medium term, an objectively-assessed parameter such as AK lesion area and the haemoglobin content via spectral analysis suggesting that this strategy could improve the skin area affected by the AK process.