A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds

NCT07467239 | Recruiting

• 1 other identifier: LF30_NLF_EU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nasolabial Folds, Wrinkles

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  Baseline to Month 1,3,6,9

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

  Month 1,3,6,9,12

• Subject Satisfaction With Treatment Using a Five-Point Likert Scale

  Month 12

• Proportion of Subjects Receiving Touch-up Treatment

  Month 1

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

  Baseline through Month 12

Study Arms (2)

DMFI300

EXPERIMENTAL

Injection of DMFI300

Device: DMFI300

Ellansé-M

ACTIVE COMPARATOR

Injection of Ellansé-M

Device: Ellansé-M

Interventions

DMFI300 DEVICE

Injection of DMFI300 for nasolabial folds.

DMFI300

Ellansé-M DEVICE

Injection of Ellansé-M for nasolabial folds.

Ellansé-M

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samyang Biopharmaceuticals Corporation: lead

Study Sites (1)

Ocean Clinic

Marbella, Spain

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)