Study to Evaluate Satisfaction After Treatment With Restylane

Galderma

Status: Completed

Conditions: Cheek Augmentation

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04638816

05DF2004

Details and patient eligibility

About

Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Restylane

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Signed and dated informed consent to participate in the study
• Adult women who intend to undergo cheek augmentation

Exclusion criteria

• Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics
• Subjects with a previous implant other than HA in or near the intended treatment site
• Participation in any other clinical study within three (3) months before treatment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Restylane Volyme

Experimental group

Description:

Hyaluronic Acid

Treatment:

Device: Restylane Volyme

Restylane Lyft Lidocaine

Experimental group

Description:

Hyaluronic Acid

Treatment:

Device: Restylane Lyft Lidocaine