This is a prospective, randomized, controlled clinical investigation designed to evaluate the performance and safety of DMFI300 for the treatment of nasolabial folds. 30 adult participants will receive treatment with the investigational device and the comparator device using a split-face design. 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 Wrinkle Severity Rating Scale (WSRS) for both nasolabial folds.
Willing and able to provide written informed consent.
Willing to comply with study procedures and follow-up visits.
Use of antiplatelet agents, vitamin E, or NSAIDs within 2 weeks before screening or planned use within 2 weeks after treatment.
History or presence of bleeding disorders.
Participation in another clinical investigation within 1 month prior to screening.
Pregnant or breastfeeding women, or women planning pregnancy during the study.
Parallel
DMFI300
DeviceInjection of DMFI300 for nasolabial folds.
Ellansé-M
DeviceInjection of Ellansé-M for nasolabial folds.
Change from Baseline in Wrinkle Severity Rating Scale (WSRS) as Assessed by the Evaluating 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 blinded EI will assess the change from baseline to Month 12 for each nasolabial fold treated with DMFI300 or Ellansé-M.
Change from Baseline in Wrinkle Severity Rating Scale (WSRS) Assessed by the Evaluating 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). Changes from baseline will be assessed for each nasolabial fold treated with DMFI300 or Ellansé-M by the EI and TI.
Global Aesthetic Improvement Scale (GAIS) Assessed by the Treating Investigator (TI) and the Subject
GAIS is a 5-point global improvement scale (3 = Very Much Improved, 2 = Much Improved, 1 = Improved, 0 = No Change, -1 = Worse). The TI and subject will independently assess GAIS for each nasolabial fold treated with DMFI300 or Ellansé-M.
Subject Satisfaction With Treatment Using a Five-Point Likert Scale
Subject satisfaction with treatment will be evaluated using a five-point Likert scale for each nasolabial fold treated with DMFI300 or Ellansé-M.
Proportion of Subjects Receiving Touch-up Treatment
Proportion of subjects who receive additional touch-up treatment at Month 1 after the initial injection if suboptimal improvement is observed.
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