RecruitingNot ApplicableNCT07292779

A Prospective Clinical Investigation of DMFI150 for Treating Nasolabial Folds

A Prospective, Clinical Investigation to Evaluate the Performance and Safety of DMFI150 for the Treatment of Nasolabial Folds


Sponsor

Samyang Biopharmaceuticals Corporation

Enrollment

30 participants

Start Date

Nov 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria5

  • 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.

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Interventions

DEVICEDMFI150

Injection of DMFI150 for nasolabial folds.


Locations(1)

Ocean Clinic

Marbella, Spain

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NCT07292779


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