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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01565915

Enrollment

221

Registered

2012-03-29

Start date

2012-03-31

Completion date

2013-12-31

Last updated

2013-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Volume

Brief summary

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

Interventions

DEVICEPerlane-L

Perlane-L Injection in the midface

OTHERNon-treatment

Non-treatment Arm

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Facial fullness using midface scale	Week 8	Change in facial fullness using midface scale.

Secondary

Measure	Time frame	Description
Facial fullness using the midface scale	Up to 12-months post treatment	Change in facial fullness using midface scale.
Subject satisfaction using the GAIS	Up to 12-months post treatment	Compare treatment satisfaction as compared to no treatment, on the Global Aesthetic Improvement Scale (GAIS)
Aesthetic improvement	Up to 12-months post treatment	A subjective assessment of aesthetic improvement post baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026