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NCT06961448
A Study in Adults Evaluating Polycaprolactone Microsphere Filler for Treatment of Moderate to Severe Nasolabial Folds
NA trial testing Hyaluronate Gel for Injection in Nasolabial Fold Correction in 208 participants. Not yet recruiting.
1 May 2026
Quick facts
| Lead sponsor | Samyang Biopharmaceuticals Corporation |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 208 |
| Start date | 1 May 2025 |
| Primary completion | 1 May 2026 |
| Estimated completion | 1 November 2026 |
Drugs / interventions tested
- Hyaluronate Gel for Injection
- Polycaprolactone microsphere filler
Conditions studied
- Nasolabial Fold Correction — all drugs for Nasolabial Fold Correction →
Sponsor
Samyang Biopharmaceuticals Corporation — full company profile →
Who can join
18 and older, any sex, with Nasolabial Fold Correction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to evaluate the safety and efficacy of polycaprolactone microsphere filler (Lafullen) for the correction of moderate to severe nasolabial folds in adults aged 18 and above, regardless of gender. The main questions it aims to answer are: * Does Lafullen improve wrinkle severity in the nasolabial fold area at 48 weeks post-injection (WSRS responder rate)? * Is Lafullen superior to the control product (Restylane, a hyaluronic acid filler) in terms of long-term wrinkle correction and safety? Researchers will compare Lafullen (polycaprolactone filler) with Restylane (modified sodium hyaluronate gel) to see if Lafullen provides superior wrinkle correction at 12 months post-injection. Participants will: * Receive either Lafullen or Restylane via injection in the nasolabial fold area. * Optionally receive a touch-up injection at 4 weeks after the first treatment if needed. * Undergo regular follow-up visits at 4, 12, 24, 36, and 48 weeks post-treatment. * Subjects in the Lafullen group will continue follow-up up to 72 weeks to assess long-term efficacy and safety. * Be assessed through clinical photography, pain scale (VAS), satisfaction questionnaires, and safety evaluations (e.g., AEs, vital signs, lab tests).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06961448
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Nasolabial Fold Correction
Currently open trials in the same condition.
- NCT07160777 — Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation · active not recruiting
Other Samyang Biopharmaceuticals Corporation trials
Trials by the same sponsor.
- NCT07467239 — A Prospective Clinical Investigation of DMFI300 for Treating Nasolabial Folds · NA · recruiting
- NCT06402058 — A Study Comparing DMSB01 and Rejuran® for Temporary Crow's Feet Lines Improvement · NA · not yet recruiting
- NCT06295172 — A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement · NA · not yet recruiting
- NCT06093321 — A Study Comparing SYB PDO Thread and MINT Lift® for Temporary Nasolabial Fold Improvement · NA · unknown
- NCT05645809 — Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture in Laparoscopic Surgery · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06961448 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Samyang Biopharmaceuticals Corporation
- Last refreshed: 8 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06961448.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing