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

Not Applicable

• Conditions: Facial Volume
• Interventions: Other: Non-treatment; Device: Perlane-L

• Registration Number: NCT01565915
• Lead Sponsor: Medicis Global Service Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-12
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-29
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-20
• Last Update Posted: 2013-08-21
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 221

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Treatment	Non-treatment	Non-Treatment Arm
Perlane-L	Perlane-L	Perlane-L treatment

Primary Outcome Measures

Name	Time	Method
Facial fullness using midface scale	Week 8	Change in facial fullness using midface scale.

Secondary Outcome Measures

Name	Time	Method
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