Clinical Trials in Spain / NCT07292779
Recruiting
Not applicable
A Prospective Clinical Investigation of DMFI150 for Treating Nasolabial Folds
NCT07292779 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Nasolabial Folds, Wrinkles
Investigational drug(s) / intervention(s)
DMFI150
DMFI150: Injection of DMFI150 for nasolabial folds.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Change from Baseline in Wrinkle Severity Rating Scale (WSRS) as Assessed by the Evaluator 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 EI will assess the change from baseline to Month 12.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Ocean Clinic | Marbella | Spain | Recruiting |
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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 NCT07292779 on ClinicalTrials.gov ↗ ← All trials in Spain