Nasolabial Folds, Wrinkles
Conditions
Brief 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.
Interventions
DEVICEDMFI150
Injection of DMFI150 for nasolabial folds.
Sponsors
Samyang Biopharmaceuticals Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Wrinkle Severity Rating Scale (WSRS) as Assessed by the Evaluator 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 EI will assess the change from baseline to Month 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Wrinkle Severity Rating Scale (WSRS) Assessed by the Evaluator Investigator (EI) and the Treating Investigator (TI) | Baseline to Month 1,3,6,9,12 | 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. 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 | Baseline to 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). 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) | Baseline through Month 12 | All TRAEs, AEs, SAEs, and DDs will be recorded and assessed according to the clinical investigation plan. |
Countries
Spain
Outcome results
None listed