A Prospective Clinical Investigation of DMFI300 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, 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • DMFI300
  • Ellansé-M

Treatment groups

30 Participants
are divided into 2 treatment groups