A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds

Samyang Biopharmaceuticals Corporation30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Nasolabial Folds, Wrinkles

Interventions

DMFI300DEVICE

Injection of DMFI300 for nasolabial folds.

Ellansé-MDEVICE

Injection of Ellansé-M 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 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.

Locations (1)

Ocean Clinic

Marbella, Spain

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Baseline to Month 12

Secondary Outcomes

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.

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

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.

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

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.

Time frame: Month 12

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.

Time frame: Month 1

Data from ClinicalTrials.gov

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