CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 168 enrolled
Drug / intervention
Restylane Volymedevice
Likely dose
Restylane Volyme via subcutaneous injection (specific volume not stated)AI-extracted
Key inclusion· 4
  • Men or women aged 18 years or older of Chinese origin
  • Seeking augmentation therapy for the midface
  • MMVS score of 2, 3, or 4 on each side of the face as assessed by the blinded evaluator
  • Willing to abstain from other facial plastic surgical or cosmetic procedures below the lower orbital rim during the study
Key exclusion· 5
  • Known or previous allergy/hypersensitivity to hyaluronic acid gel, lidocaine, or amide-type local anesthetics
  • Previous surgery or tattoo in the treatment area
  • Previous permanent or semi-permanent facial fillers, autologous fat, lifting threads, or permanent implants below the lower orbital rim
  • Previous hyaluronic acid or collagen-based biodegradable fillers, or neurotoxins within 9 months before treatment

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

Search/NCT03289052
NCT03289052N/ACompleted

A Randomized, Multi-center, Evaluator-blinded, No-treatment Controlled Study to Evaluate the Effectiveness and Safety of Restylane Volyme for Correction of Midface Volume Deficit and/or Midface Contour Deficiency

Galderma R&D·interventional·Posted Sep 20, 2017·Updated May 12, 2023

In Brief

A clinical study evaluating Restylane Volyme for Midface Volume Deficit. Completed, enrolled 168 participants across 1 site.

Detailed Summary

This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Midface Volume Deficit and/or Midface Contour Deficiency.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 20, 2017
Enrollment StartDec 1, 2017
Primary CompletionJan 31, 2019
Study CompletionJul 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.8 years ago

Interventions

Restylane Volymedevice

Subcutis injection