MD60000: a gel filler for aging-related skin imperfections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, single-center study evaluating the aesthetic performance and safety of the MD60000 intradermal gel containing hyaluronic acid and PLA. Participants receive up to 2 mL per session in two injections (Baseline and Day 21) and are followed for up to 65 days. The trial follows MDR 2017/745 and ISO 14155 guidelines, with no control group because spontaneous improvement of static wrinkles is not expected. The primary focus is regulatory conformity and practical performance in real-world use. Thirty-three to forty-three adults with LWSS scores ≥1 will be enrolled, with safety and efficacy assessments conducted at defined time points.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinica santa maria la bruna
  Torre del Greco, Napoli, Italy Recruiting

Study contacts

• Study coordinator: Grazia Iannacci
• Email: Executive.assistant@webpromoitalia.com
• Phone: +39 331 591 3106

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.