Actively Recruiting
A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds
Led by Samyang Biopharmaceuticals Corporation · Updated on 2026-03-12
30
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ocean Clinic
Marbella, Spain
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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