A Prospective Clinical Investigation of DMFI150 for Treating Nasolabial Folds

Samyang Biopharmaceuticals Corporation30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nasolabial Folds, Wrinkles

Interventions

DMFI150DEVICE

Injection of DMFI150 for nasolabial folds.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ocean Clinic

Marbella, Spain

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Baseline to Month 12

Secondary Outcomes

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.

Time frame: Baseline to Month 1,3,6,9,12

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.

Time frame: Baseline to Month 1,3,6,9,12

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.

Time frame: Baseline through Month 12

Data from ClinicalTrials.gov

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