Clinical Trials in Spain / NCT07467239
Recruiting
Not applicable
A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds
NCT07467239 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Nasolabial Folds, Wrinkles
Investigational drug(s) / intervention(s)
DMFI300Ellansé-M
DMFI300: Injection of DMFI300 for nasolabial folds.
Ellansé-M: Injection of Ellansé-M for nasolabial folds.
Study summary
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
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.
Primary outcome measure(s)
- Change from Baseline in Wrinkle Severity Rating Scale (WSRS) as Assessed by the Evaluating Investigator (EI) — Baseline to Month 12
WSRS is a validated 5-point ordinal scale used to evaluate wrinkle severity (1 = Absent, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme). Higher scores indicate more severe wrinkles. The blinded EI will assess the change from baseline to Month 12 for each nasolabial fold treated with DMFI300 or Ellansé-M.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Ocean Clinic | Marbella | Spain | Recruiting |
More Samyang Biopharmaceuticals Corporation trials in Spain
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07467239 on ClinicalTrials.gov ↗ ← All trials in Spain