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
Samyang Biopharmaceuticals Corporation
30 participants
Nov 24, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria4
- 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 Criteria5
- 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.
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Interventions
Injection of DMFI150 for nasolabial folds.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07292779