A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds

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

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 Overview

• Status: Recruiting
• Conditions: Nasolabial Folds, Wrinkles
• Intervention / Treatment: Device: DMFI300; Device: Ellansé-M

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Marbella, Spain
    • Recruiting
    • Ocean Clinic
    • Contact: Vanessa; Phone Number: +34 951 775 518; Email: admon@oceanclinic.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DMFI300; Injection of DMFI300	Device: DMFI300; Injection of DMFI300 for nasolabial folds.
Active Comparator: Ellansé-M; Injection of Ellansé-M	Device: Ellansé-M; Injection of Ellansé-M for nasolabial folds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Month 1
Incidence of Treatment-Related Adverse Events (TRAEs), Adverse Events (AEs), Serious Adverse Events (SAEs), and Device Deficiencies (DDs)	All TRAEs, AEs, SAEs, and device deficiencies will be recorded and evaluated throughout the clinical investigation.	Baseline through Month 12

Collaborators and Investigators

• Sponsor: Samyang Biopharmaceuticals Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: LF30_NLF_EU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No