CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
Restylane Volyme +2 moredevice
Likely dose
Restylane Volyme, Restylane Defyne, and Restylane Lyft Lidocaine — doses individualized per treatment algorithmAI-extracted
Key inclusion· 2
  • ✓Age 25 to 55 years old
  • ✓Requires lifting, contouring, or volumization of the midface
Key exclusion· 5
  • ✕Known or previous allergy/hypersensitivity to hyaluronic acid gel or lidocaine
  • ✕Previous use of permanent or semi-permanent facial tissue augmentation (including lifting threads, permanent implants, or autologous fat) in the treatment area
  • ✕Previous use of HA or collagen-based facial tissue augmentation in any facial area
  • ✕Previous use of neurotoxin or previous facial surgery

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

Search/NCT03869450
NCT03869450N/ACompleted
CompareCT.gov

A Multi-center, Evaluator-blinded Study to Evaluate Effectiveness and Safety of HA Fillers for Lifting, Contouring and Correcting Volume Deficiency of the Midface Using an Individualized Treatment Algorithm

Galderma R&D·interventional·Posted Mar 11, 2019·Updated Aug 26, 2022

In Brief

A clinical study evaluating Restylane Volyme, Restylane Defyne, and 1 other intervention for Volume Deficiency of the Midface. Completed, enrolled 90 participants across 3 sites in 3 countries.

Detailed Summary

The purpose of the study is to investigate the degree of improvement in appearance after treatment with different hyaluronic acid (HA) fillers. Product selection is based on Investigator assessment of participant tissue coverage and main treatment goal (volumizing, lifting or contouring).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVolume Deficiency of the Midface
CountriesGermany, Italy, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 11, 2019
Enrollment StartNov 9, 2018
Primary CompletionAug 30, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.3 years ago

Interventions

Restylane Volymedevice

Hyaluronic based filler

Restylane Defynedevice

Hyaluronic based filler

Restylane Lyft Lidocainedevice

Hyaluronic based filler