Study to Evaluate Satisfaction After Treatment With Restylane

Galderma R&D60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cheek Augmentation

Interventions

Restylane VolymeDEVICE

Hyaluronic Acid: Injectable gel for contouring effect (of cheek volumization).

Restylane Lyft LidocaineDEVICE

Hyaluronic Acid: Injectable gel for projection effect (of cheek augmentation).

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Galderma Study Site

Vancouver, British Columbia, Canada

Galderma Study Site

Woodbridge, Ontario, Canada

Galderma Study Site

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS

The 7-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the treatment area (cheeks) compared to pre-treatment. The rating is very much improved, much improved, improved, no change, worse, much worse, or very much worse.

Time frame: 4 weeks after last treatment, up to 6 weeks

Data from ClinicalTrials.gov

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