About this trial
This is a prospective clinical investigation designed to evaluate the performance and safety of DMFI150 for the treatment of nasolabial folds. 30 adult participants will receive a single treatment with the investigational device. The study will assess wrinkle severity using validated aesthetic evaluation scales, as well as overall safety.
Eligibility criteria
Qualifiers
Men and women aged 18-70 years.
Score of 3 to 4 on the WSRS (1 = absent, 2 = mild, 3 = moderate, 4 = severe, and 5 = extreme) for both nasolabial folds.
Able and willing to provide written informed consent.
Willing to refrain from facial cosmetic procedures during the study.
Disqualifiers
Use of antiplatelet agents, vitamin E, or NSAIDs within 2 weeks before screening or 2 weeks after treatment.
History or current bleeding disorders.
Participation in another clinical trial within 1 month before screening.
Pregnant or breastfeeding women, or planning pregnancy.
Trial design
Treatments tested in this trial
- DMFI150