Efficacy and Safety of Perlane-L in the Correction of Midface Volume Deficit

N/AUnknownNCT01565915

Medicis Global Service Corporation221 enrolled

Overview

The purpose of this study is to determine if Perlane-L is safe in increasing cheek volume.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

221

Conditions

Facial Volume

Interventions

Perlane-LDEVICE

Perlane-L Injection in the midface

Non-treatmentOTHER

Non-treatment Arm

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Loss of Fullness in Midface Area * Other items as identified in the protocol Exclusion Criteria: * History of allergy or hypersensitivity to injectable hyaluronic acid gel or lidocaine. * Other items as identified in the protocol

Locations (11)

Unnamed facility

Beverly Hills, California, United States

Unnamed facility

San Francisco, California, United States

Unnamed facility

Vista, California, United States

Unnamed facility

Aventura, Florida, United States

Outcomes

Primary Outcomes

Facial fullness using midface scale

Change in facial fullness using midface scale.

Time frame: Week 8

Secondary Outcomes

Facial fullness using the midface scale

Change in facial fullness using midface scale.

Time frame: Up to 12-months post treatment

Subject satisfaction using the GAIS

Compare treatment satisfaction as compared to no treatment, on the Global Aesthetic Improvement Scale (GAIS)

Time frame: Up to 12-months post treatment

Aesthetic improvement

A subjective assessment of aesthetic improvement post baseline

Time frame: Up to 12-months post treatment

Data from ClinicalTrials.gov

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