A Prospective Clinical Investigation of DMFI150 for Treating Nasolabial Folds

NCT07292779 | Recruiting

• 1 other identifier: LF15_NLF_EU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nasolabial Folds, Wrinkles

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Month 12

Secondary Outcomes (3)

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

  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

  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)

  Baseline through Month 12

Study Arms (1)

DMFI150

EXPERIMENTAL

Single injection of DMFI150

Device: DMFI150

Interventions

DMFI150 DEVICE

Injection of DMFI150 for nasolabial folds.

DMFI150

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samyang Biopharmaceuticals Corporation: lead

Study Sites (1)

Ocean Clinic

Marbella, Spain

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 18, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)