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A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds

RecruitingNAAges 18 Years - 70 YearsAllSamyang Biopharmaceuticals Corporation
NCT07467239 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. * Willing to refrain from other facial cosmetic procedures affecting the nasolabial folds during the study. Exclusion Criteria: * 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. * Women of childbearing potential not using an effective method of contraception.
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What it tests

  • DMFI300
  • Ellansé-M
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Where

1 site
Ocean Clinic
Marbella, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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