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

Not Applicable

Completed

• Conditions: Volume Deficiency of the Midface
• Interventions: Device: Restylane Volyme; Device: Restylane Defyne; Device: Restylane Lyft Lidocaine

• Registration Number: NCT03869450
• Lead Sponsor: Galderma R&D

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-09
• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-11
• Primary Completion: 2019-08-30
• Study Completion: 2019-08-30
• Results First Submitted: 2020-03-17
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-01
• Results First Posted: 2020-04-02
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restylane Volyme	Restylane Volyme	According to the treatment algorithm, treated with Restylane Volyme
Restylane Defyne	Restylane Defyne	According to the treatment algorithm, treated with Restylane Defyne
Restylane Lyft Lidocaine	Restylane Lyft Lidocaine	According to the treatment algorithm, treated with Restylane Lyft Lidocaine

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Aesthetic Improvement of Midface	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Improved Midface Volume	8 weeks	A blinded evaluator assessed the fullness of the midface by using a 4-graded scale where 1= fairly full and 4= substantial loss of fullness.; Improved midface volume was defined as at least a 1-grade decrease from baseline.
Percentage of Participants Assessed as Having Natural Treatment Results	8 weeks	Blinded evaluator assessed participants by answering Strongly agree/Agree/Neither agree nor disagree/Disagree/Strongly disagree to the question "Are the subject's treatment results natural looking?". Having natural treatment results is defined as being assessed with answers Strongly agree or Agree.

Trial Locations

Locations (1)

Galderma Research Site; 🇬🇧 Edinburgh, United Kingdom