Clinical Trial for Assessing the Effectiveness and Tolerability of the Medical Device Sunekos 200, Applied with Electroporator in Skin Ageing

Background: Assessment of the effectiveness and tolerability, with regard to facial photoageing, of a solution containing a blend of amino acids and low molecular weight hyaluronic acid (Sunekos 200), delivered using an electroporator, capable of stimulating the production of new collagen and elastin. Target: The objective of this study was to verify whether the same effects, in terms of effectiveness and tolerability, are achieved when delivering the product Sunekos 200 with an electroporator rather than injecting it. Method: The study was performed on healthy female patients, aged between 45 and 65 years old. 30 patients were treated on the face and 10 patients were treated on the hands. All patients underwent 4 sessions of electric traction every week. The patients were assessed at baseline, after 4 weeks and 1 month after the end of the sessions (T0-T1-T2), using validated clinical scales, subjective and objective assessments (skin check-up) and a photographic evaluation (T0-T1-T2). All the patients were asked to answer a self-assessment questionnaire after the end of the treatment. Results: In all cases, the results obtained showed an improvement in all the clinical and subjective assessments and in most of the objective instrumental parameters. In any case, the clearest results appear in the space of approximately one month, with a distinct visible improvement in the degree of ageing of the skin, its hydration and sebum levels. The overall evaluation expressed by both the volunteers and the testers (Oesse Total Checkup - Casale Monferrato (AL) - Italy), in terms of effectiveness and tolerability, was good/excellent. Conclusions: The results obtained confirm that by delivering Sunekos 200 with an electroporator, as in the intradermal therapy technique, we obtain an improvement in the hydration of the skin, its sebum levels, firmness, and the number of micro-wrinkles on the surface. The results are less visible and less long-lasting than those achieved by introducing the device with intradermal therapy technique. Delivering the product by way of electroporation to the hands proved extremely effective, almost immediately generating results. This type of application is in any case preferable for all patients with needle phobia or with a particularly active social life. Based on the objective results and those resulting from the clinical analyses, this type of application method can be a valid alternative to the traditional intradermal treatment method.