What this means
This study plans to test a skin device on people with facial wrinkles. It has not started enrolling, and no results have been posted yet, so it cannot show whether the device works.
Plain-English summary written by an AI model from the registry listing.
- Status
- Opening soon
- Who can join
- Ages 18–65 · 43 adults with facial wrinkles
- Where
- 1 site
The science
- Registered title
- Evaluation of MD60002 Device for Facial Skin Aging
- Trial ID
- NCT07881926 ↗
- Phase
- Not applicable
- Study type
- interventional
- Conditions
- Facial Wrinkles, Skin Aging, Skin Imperfections
- What is tested
- Device: MD60002
- Sponsor
- Promoitalia Group Spa
- Ages
- 18 Years to 65 Years
- Dates
- First posted Oct 20, 2026 · updated Oct 20, 2026
Registry 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.
Sites (1)
- Clinica santa maria la bruna, Torre del Greco, Napoli, Italy