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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-09

Study Completion Date

2019-08-30

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).

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Detailed Description

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Conditions

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Volume Deficiency of the Midface

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Restylane Volyme

According to the treatment algorithm, treated with Restylane Volyme

Group Type EXPERIMENTAL

Restylane Volyme

Intervention Type DEVICE

Hyaluronic based filler

Restylane Defyne

According to the treatment algorithm, treated with Restylane Defyne

Group Type EXPERIMENTAL

Restylane Defyne

Intervention Type DEVICE

Hyaluronic based filler

Restylane Lyft Lidocaine

According to the treatment algorithm, treated with Restylane Lyft Lidocaine

Group Type EXPERIMENTAL

Restylane Lyft Lidocaine

Intervention Type DEVICE

Hyaluronic based filler

Interventions

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Restylane Volyme

Hyaluronic based filler

Intervention Type DEVICE

Restylane Defyne

Hyaluronic based filler

Intervention Type DEVICE

Restylane Lyft Lidocaine

Hyaluronic based filler

Intervention Type DEVICE

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No