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NCT Number: NCT07467239

A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds

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.

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Key information

Conditions

Nasolabial Folds, Wrinkles

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DMFI300

Device

Injection of DMFI300 for nasolabial folds.

Ellansé-M

Device

Injection of Ellansé-M for nasolabial folds.

Primary outcomes

  1. Change from Baseline in Wrinkle Severity Rating Scale (WSRS) as Assessed by the Evaluating Investigator (EI)

    Time frame: 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 outcomes

  1. Change from Baseline in Wrinkle Severity Rating Scale (WSRS) Assessed by the Evaluating Investigator (EI) and the Treating Investigator (TI)

    Time frame: 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.

  2. Global Aesthetic Improvement Scale (GAIS) Assessed by the Treating Investigator (TI) and the Subject

    Time frame: 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.

  3. Subject Satisfaction With Treatment Using a Five-Point Likert Scale

    Time frame: 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.

  4. Proportion of Subjects Receiving Touch-up Treatment

    Time frame: Month 1

    Proportion of subjects who receive additional touch-up treatment at Month 1 after the initial injection if suboptimal improvement is observed.

  5. Incidence of Treatment-Related Adverse Events (TRAEs), Adverse Events (AEs), Serious Adverse Events (SAEs), and Device Deficiencies (DDs)

    Time frame: Baseline through Month 12

    All TRAEs, AEs, SAEs, and device deficiencies will be recorded and evaluated throughout the clinical investigation.

Sponsors and collaborators

Lead sponsor

Samyang Biopharmaceuticals Corporation

Industry

Registry information

Official study title

A Prospective, Participant- and Evaluator-blinded, Randomized, Controlled, Split-face Clinical Investigation to Evaluate the Performance and Safety of Polycaprolactone 300 (DMFI300) for the Treatment of Nasolabial Folds

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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