A Prospective Clinical Investigation of DMFI150 for Treating Nasolabial Folds

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSamyang Biopharmaceuticals Corporation

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • DMFI150

Treatment groups

30 Participants
are divided into 1 treatment group