18 and older, any sex, with Nasolabial Folds in Chinese Population. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Responders, Defined by at Least 1-point Improvement From Baseline on the WSRS.Primary· 6 month
The Wrinkle Severity Rating Scale (WSRS) is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds.
Grade 1 Absent: No visible fold; continuous skin line Grade 2 Mild: Shallow but visible fold with a slight indentation; minor facial feature Implant is expected to produce a slight improvement in appearance Grade 3 Moderate: Moderately deep folds; clear facial feature visible at normal appearance but not when stretched. Excellent correction is expected from injectable implant Grade 4 Severe: Very long and deep fold; prominent facial feature; l
Group
Value
95% CI
Restylane Defyne in the Right NLF Followed by Restylane in the Left NLF
72.9
66.3 – 79.6
Restylane in the Right NLF Followed by Restylane Defyne in the Left NLF
72.8
66.1 – 79.5
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a randomized, split face, multicenter study to evaluate the efficacy and safety of Restylane Defyne compared to Restylane in correction of NLFs.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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· NA
· completed
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· NA
· completed
NCT04520997 — Restylane Defyne in a Stepwise Treatment Approach
· NA
· completed
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· NA
· completed
NCT03869450 — A Study to Evaluate Effectiveness and Safety of Hyaluronic Acid (HA) Fillers
· NA
· completed
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Trials by the same sponsor.
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· NA
· not yet recruiting
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· Phase 3
· recruiting
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· Phase 4
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Galderma R&D
Last refreshed: 3 November 2023
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/NCT03003130.