A Prospective Clinical Investigation of DMFI150 for Treating Nasolabial Folds

A Prospective, Clinical Investigation to Evaluate the Performance and Safety of DMFI150 for the Treatment of Nasolabial Folds

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Women of childbearing potential not using effective contraception.