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&D1 site in 1 country90 target enrollmentNovember 9, 2018

ConditionsVolume Deficiency of the Midface

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Volume Deficiency of the Midface
Sponsor: Galderma R&D
Enrollment: 90
Locations: 1
Primary Endpoint: Percentage of Participants With Aesthetic Improvement of Midface
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

November 9, 2018

End Date

August 30, 2019

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Galderma R&D

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Percentage of Participants With Aesthetic Improvement of Midface

Time Frame: 8 weeks

A blinded evaluator assesses the improvement compared to baseline (pre-treatment) using a 5-graded scale; Worse, No change, Improved, Much improved or Very much improved. Aesthetic improvement of midface is defined as those participants assessed as Improved, Much improved or Very much improved.