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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Volume Deficiency of the Midface

Intervention / Treatment
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* Device: Restylane Volyme
* Device: Restylane Defyne
* Device: Restylane Lyft Lidocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restylane Volyme<br>According to the treatment algorithm, treated with Restylane Volyme | Device: Restylane Volyme<br>* Hyaluronic based filler<br>|
| Experimental: Restylane Defyne<br>According to the treatment algorithm, treated with Restylane Defyne | Device: Restylane Defyne<br>* Hyaluronic based filler<br>|
| Experimental: Restylane Lyft Lidocaine<br>According to the treatment algorithm, treated with Restylane Lyft Lidocaine | Device: Restylane Lyft Lidocaine<br>* Hyaluronic based filler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Aesthetic Improvement of Midface | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Improved Midface Volume | 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. | 8 weeks | 
| Percentage of Participants Assessed as Having Natural Treatment Results | 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. | 8 weeks |