Nasolabial Folds, Wrinkles
Conditions
Brief summary
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.
Interventions
DEVICEDMFI300
Injection of DMFI300 for nasolabial folds.
DEVICEEllansé-M
Injection of Ellansé-M for nasolabial folds.
Sponsors
Samyang Biopharmaceuticals Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Willing to refrain from other facial cosmetic procedures affecting the nasolabial folds during the study.
Exclusion criteria
* 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. * Women of childbearing potential not using an effective method of contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Wrinkle Severity Rating Scale (WSRS) as Assessed by the Evaluating Investigator (EI) | Baseline to Month 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Wrinkle Severity Rating Scale (WSRS) Assessed by the Evaluating Investigator (EI) and the Treating Investigator (TI) | Baseline to Month 1,3,6,9 | 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 | Month 1,3,6,9,12 | 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 | Month 12 | 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 | Month 1 | Proportion of subjects who receive additional touch-up treatment at Month 1 after the initial injection if suboptimal improvement is observed. |
| Incidence of Treatment-Related Adverse Events (TRAEs), Adverse Events (AEs), Serious Adverse Events (SAEs), and Device Deficiencies (DDs) | Baseline through Month 12 | All TRAEs, AEs, SAEs, and device deficiencies will be recorded and evaluated throughout the clinical investigation. |
Countries
Spain
Outcome results
None listed