A Prospective Clinical Investigation of DMFI150 for Treating Nasolabial Folds

Samyang Biopharmaceuticals Corporation

Status

Enrolling

Conditions

Nasolabial Folds, Wrinkles

Treatments

Device: DMFI150

Study type

Interventional

Funder types

Industry

Identifiers

NCT07292779

LF15_NLF_EU

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.