RecruitingNot Applicable

A Prospective Clinical Investigation of DMFI150 for Treating Nasolabial Folds

Spain30 participantsStarted 2025-11-24

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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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.

What they're measuring

Change from Baseline in Wrinkle Severity Rating Scale (WSRS) as Assessed by the Evaluator Investigator (EI)

Timeframe: Baseline to Month 12

Trial details

NCT IDNCT07292779

SponsorSamyang Biopharmaceuticals Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Nasolabial Folds, Wrinkles trials