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

RecruitingNAAges 18 Years - 65 YearsAllPromoitalia Group Spa
NCT07873112 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 con

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults aged between 18 and 65 years. * Presence of facial skin defects/wrinkles with a Lemperle Wrinkle Severity Scale (LWSS) score ≥ 1 at baseline. * Signed written informed consent to participate in the study. Exclusion Criteria: * Subjects aged under 18 or over 65 years. * Presence of concomitant skin diseases, active infections, or inflammation in the area to be treated. * Known severe allergies, hypersensitivity to hyaluronic acid or any component of the investigational product, or history of anaphylactic reactions. * History of autoimmune diseases, severe chronic/systemic pathologies, or bleeding/coagulation disorders. * History of hypertrophic scars, keloids, or abnormal cicatrization. * Recent aesthetic treatments (e.g., dermal fillers, botulinum toxin, laser, chemical peels) in the target anatomical area within the preceding months. * Pregnant or breastfeeding women (negative pregnancy test required at screening for women of childbearing potential). * Concomitant conditions or therapies that, in the opinion of the Investigator, could compromise subject safety or interfere with study evaluations.
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What it tests

  • MD60000
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Where

1 site
Clinica santa maria la bruna
Torre del Greco, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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