Trials / Recruiting
RecruitingNCT07467239
A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds
A Prospective, Participant- and Evaluator-blinded, Randomized, Controlled, Split-face Clinical Investigation to Evaluate the Performance and Safety of Polycaprolactone 300 (DMFI300) for the Treatment of Nasolabial Folds
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Samyang Biopharmaceuticals Corporation · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DMFI300 | Injection of DMFI300 for nasolabial folds. |
| DEVICE | Ellansé-M | Injection of Ellansé-M for nasolabial folds. |
Timeline
- Start date
- 2026-03-02
- Primary completion
- 2027-03-31
- Completion
- 2027-05-31
- First posted
- 2026-03-12
- Last updated
- 2026-03-12
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT07467239. Inclusion in this directory is not an endorsement.