Clinical Research Directory

Evaluation of the Performance and Safety of the MD60000 Device in the Treatment of Skin Imperfections Due to Aging.

Sponsor: Promoitalia Group Spa

Summary

Here is the English translation of the summary: The Clinical Investigation Plan with code CIP-01-25 outlines a single-center, uncontrolled, single-arm clinical study sponsored by Promoitalia Group S.p.A. and conducted at the Casa di Cura Santa Maria La Bruna in Torre del Greco under the responsibility of Principal Investigator Giuseppe Ferraro, with Teia Research S.r.l. acting as the CRO. The primary objective of the study is to evaluate the aesthetic performance and safety of the MD60000 medical device, an intradermal, biodegradable, sterile, and isotonic gel based on 3.3% linear hyaluronic acid integrated with PLA, intended for the correction of skin imperfections caused by physiological skin aging, such as facial wrinkles. The investigation is conducted pursuant to Article 61 of the European Medical Device Regulation 2017/745 (MDR) in order to collect clinical data for regulatory conformity assessment, adhering to ISO 14155 standards and the Declaration of Helsinki. The study design involves enrolling forty-three adult patients aged between eighteen and sixty-five years with facial skin defects characterized by a baseline score of one or higher on the Lemperle Wrinkle Severity Scale. Patients with skin diseases, active infections, or recent aesthetic treatments in the same anatomical area are excluded, as well as pregnant or breastfeeding women, individuals with a history of allergic reactions to the components, autoimmune diseases, coagulation disorders, or a predisposition to hypertrophic scars or keloids. Participation for each subject ranges between forty-five and sixty-five days, while the overall estimated duration of the entire clinical investigation is approximately six months. The procedural pathway comprises four main visits. During the first screening and baseline visit, eligibility criteria are verified, informed consent and medical history are collected, and baseline photographic evaluations and wrinkle severity assessments are performed. If conditions permit, the first treatment session can occur on the same day, during which the clinician performs an intradermal injection of MD60000 up to a maximum volume of two milliliters. A similar second treatment session follows after an interval of at least fourteen days. The final phase consists of a follow-up visit thirty days after the second treatment, during which final photographs are taken and data regarding patient satisfaction and safety are collected. Treatment efficacy is measured using primary and secondary metrics. The primary performance endpoint is defined as the improvement in the Lemperle scale score between the initial baseline visit and the final follow-up, considered clinically relevant if a median reduction of one point or greater is achieved, confirmed statistically using the Wilcoxon signed-rank test. The secondary endpoint assesses the patient's subjective satisfaction using the Global Aesthetic Improvement Scale (GAIS) thirty days after the completion of treatment, met if at least seventy percent of participants report an rating of improved, much improved, or excellent. Regarding safety, the study evaluates the frequency, severity, and causal relationship of any adverse events or effects occurring during the investigation. The safety profile is considered acceptable in the absence of device-related serious adverse events or device deficiencies, provided that unexpected, mild, device-related adverse events do not exceed a maximum threshold of ten percent. Statistical analysis involves evaluating the Intention-to-Treat (ITT) population set for safety parameters and the Per-Protocol (PP) set for performance metrics.

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