DMFI150 to reduce nasolabial fold wrinkles
A Prospective, Clinical Investigation to Evaluate the Performance and Safety of DMFI150 for the Treatment of Nasolabial Folds
This trial will test a single treatment of DMFI150 to see if it reduces moderate-to-severe nasolabial fold wrinkles in adults aged 18–70.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Samyang Biopharmaceuticals Corporation Industry-sponsored |
| Locations | 1 site (Marbella) |
| Trial ID | NCT07292779 on ClinicalTrials.gov |
What this trial studies
This open-label interventional study will enroll 30 adults with moderate-to-severe nasolabial folds (WSRS 3–4) to receive a single treatment with the investigational device DMFI150. Investigators will use validated aesthetic scales to rate wrinkle severity at baseline and at scheduled follow-up visits and will record adverse events to characterize safety. Eligible participants must be 18–70 years old, agree to avoid other facial cosmetic procedures during the study, and meet medication and reproductive criteria. The study is conducted at a single center in Marbella, Spain.
Who should consider this trial
Good fit: Adults aged 18–70 with bilateral moderate-to-severe nasolabial folds (WSRS score 3–4) who can provide informed consent and refrain from other facial cosmetic procedures are ideal candidates.
Not a fit: People with mild or extreme wrinkle scores, active bleeding disorders, recent use of antiplatelet/NSAID/vitamin E, pregnant or breastfeeding women, or those unwilling to follow study restrictions are unlikely to benefit.
Why it matters
Potential benefit: If successful, DMFI150 could reduce the depth and appearance of nasolabial folds and offer a single-treatment cosmetic option.
How similar studies have performed: Similar injectable and device-based approaches for nasolabial folds have shown cosmetic benefit in prior studies, but DMFI150 itself appears to be a novel investigational device with limited published data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Marbella
- Ocean Clinic — Marbella, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.