A Study to Evaluate Effectiveness and Safety of Hyaluronic Acid (HA) Fillers (05DF1707)

Galderma

Status: Completed

Conditions: Volume Deficiency of the Midface

Treatments: Device: Restylane Lyft Lidocaine; Device: Restylane Volyme; Device: Restylane Defyne

Study type: Interventional

Funder types: Industry

Identifiers

NCT03869450

05DF1707

Details and patient eligibility

About

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).

Enrollment: 90 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Restylane Volyme

Experimental group

Description:

According to the treatment algorithm, treated with Restylane Volyme

Treatment:

Device: Restylane Volyme

Restylane Defyne

Experimental group

Description:

According to the treatment algorithm, treated with Restylane Defyne

Treatment:

Device: Restylane Defyne

Restylane Lyft Lidocaine

Experimental group

Description:

According to the treatment algorithm, treated with Restylane Lyft Lidocaine

Treatment:

Device: Restylane Lyft Lidocaine