CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 175 enrolled
Drug / intervention
Restylane Defyne +1 moredevice
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Age 18 years or older, Chinese origin
  • ✓Moderate to severe nasolabial folds bilaterally (WSRS 3 on both sides or 4 on both sides)
  • ✓Willing to abstain from other facial cosmetic procedures below lower orbital rim during study
Key exclusion· 5
  • ✕Known or previous allergy/hypersensitivity to hyaluronic acid gel or local anesthetics (lidocaine, amide-type)
  • ✕Previous tissue revitalization treatment below lower orbital rim within 6 months
  • ✕Previous surgery, tattoo, or permanent/semi-permanent augmentation below lower orbital rim
  • ✕Previous neurotoxins or biodegradable facial fillers (HA, collagen) below lower orbital rim within 12 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03003130
NCT03003130N/ACompleted
CompareCT.gov

A Randomized, Multi-center, Evaluator-blinded Study to Evaluate the Efficacy and Safety of Restylane Defyne Compared to Restylane for Correction of Moderate to Severe Nasolabial Folds

Galderma R&D·interventional·Posted Dec 26, 2016·Updated Nov 3, 2023

In Brief

A clinical study evaluating Restylane Defyne and Restylane for Nasolabial Folds in Chinese Population. Completed, enrolled 175 participants across 1 site.

Detailed Summary

This is a randomized, split face, multicenter study to evaluate the efficacy and safety of Restylane Defyne compared to Restylane in correction of NLFs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasolabial Folds in Chinese Population
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedDec 26, 2016
Enrollment StartJan 16, 2017
Primary CompletionMar 30, 2018
Study CompletionSep 14, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.5 years ago

Interventions

Restylane Defynedevice

Intradermal injection

Restylanedevice

Intradermal injection