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Evaluation of MD60002 Device for Facial Skin Aging
Sponsor: Promoitalia Group Spa
Summary
This single-center, non-controlled, single-arm clinical study is designed to evaluate the performance and safety of the Class III investigational device MD60002 (composed of highly purified polynucleotides at 3%) for aesthetic use in the treatment of skin imperfections and wrinkles caused by physiological facial aging. A total of 43 adult subjects presenting with facial wrinkles (Lemperle Wrinkle Severity Scale score ≥ 1) will be enrolled. Participants will receive intradermal injections of MD60002 according to a standardized protocol. The primary endpoint is the evaluation of aesthetic improvement measured by the change in the Lemperle Wrinkle Severity Scale (LWSS) score from baseline to the 30-day follow-up visit. Secondary endpoints include patient-reported subjective satisfaction evaluated via the Global Aesthetic Improvement Scale (GAIS), alongside comprehensive safety, tolerability, and device deficiency monitoring in accordance with ISO 14155 guidelines.
Official title: Performance and Safety Evaluation of the MD60002 Device in the Treatment of Skin Imperfections Due to Aging
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
43
Start Date
2026-11-20
Completion Date
2027-04-01
Last Updated
2026-10-20
Healthy Volunteers
Yes
Interventions
Device: MD60002
MD60002 is a sterile, biodegradable, isotonic intradermal gel formulated with 3% highly purified polynucleotides of fish origin in a physiological buffer. The device is supplied in a pre-filled 2 ml syringe, packaged in a blister along with sterile 30G 1/2" needles. Participants will receive slow intradermal injections of MD60002 into targeted facial areas (up to a maximum volume of 2 ml per session depending on the defect) using strict aseptic techniques and following the sponsor's provided training.
Locations (1)
Clinica santa maria la bruna
Torre del Greco, Napoli, Italy