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.
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.
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.
Single group
DMFI150
DeviceInjection of DMFI150 for nasolabial folds.
Change from Baseline in Wrinkle Severity Rating Scale (WSRS) as Assessed by the Evaluator Investigator (EI)
WSRS is a validated 5-point ordinal scale used to evaluate wrinkle severity (1 = Absent, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme). Higher scores indicate more severe wrinkles. The EI will assess the change from baseline to Month 12.
Change from Baseline in Wrinkle Severity Rating Scale (WSRS) Assessed by the Evaluator Investigator (EI) and the Treating Investigator (TI)
WSRS is a validated 5-point ordinal scale used to evaluate wrinkle severity (1 = Absent, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme). Higher scores indicate more severe wrinkles. Changes from baseline will be assessed by both EI and TI.
Change from Baseline in Global Aesthetic Improvement Scale (GAIS) Assessed by the Treating Investigator (TI) and by the Subject
GAIS is a 5-point global improvement scale (3 = Very Much Improved, 2 = Much Improved, 1 = Improved, 0 = No Change, -1 = Worse). Higher scores indicate greater improvement. Both the subject and TI will rate GAIS.
Incidence of Treatment-Related Adverse Events (TRAEs), Adverse Events (AEs), Serious Adverse Events (SAEs), and Device Deficiencies (DDs)
All TRAEs, AEs, SAEs, and DDs will be recorded and assessed according to the clinical investigation plan.
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