N/A N=90 Single-blind Treatment

A Study to Evaluate Effectiveness and Safety of Hyaluronic Acid (HA) Fillers

Volume Deficiency of the Midface

Bottom Line

View on ClinicalTrials.gov: NCT03869450 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2020

Primary outcome: Primary: Percentage of Participants With Aesthetic Improvement of Midface — 96.8; 100; 97.1 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Restylane Volyme (Device); Restylane Defyne (Device); Restylane Lyft Lidocaine (Device)
Age: Adult · 25+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Aug 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Aesthetic Improvement of Midface	96.8; 100; 97.1	—
SECONDARY Percentage of Participants With Improved Midface Volume	90.3; 87.5; 79.4	—
SECONDARY Percentage of Participants Assessed as Having Natural Treatment Results	93.5; 100; 93.9	—

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).

Eligibility Criteria

Inclusion Criteria

Male/Female 25 to 55 years old that needs lifting, contouring or volumization of the midface
Signed and dated informed consent

Exclusion Criteria

Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel and lidocain
Previous use of any permanent or semi-permanent facial tissue augmentation therapy or contouring with, lifting threads, permanent implants, or autologous fat in the treatment area
Previous use of any HA or collagen based facial tissue augmentation therapy in the facial area, any previous use of neurotoxin or any previous facial surgery
Any medical condition that in the opinion of the Investigator would make the participant unsuitable for inclusion

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03869450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.