Overview

This trial is active, not recruiting.

Condition facial volume
Treatments perlane-l, non-treatment
Sponsor Medicis Global Service Corporation
Start date March 2012
End date December 2013
Trial size 221 participants
Trial identifier NCT01565915, MA-1400-05

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Perlane-L treatment
perlane-l
Perlane-L Injection in the midface
(Sham Comparator)
Non-Treatment Arm
non-treatment
Non-treatment Arm

Primary Outcomes

Measure
Facial fullness using midface scale
time frame: Week 8

Secondary Outcomes

Measure
Facial fullness using the midface scale
time frame: Up to 12-months post treatment
Subject satisfaction using the GAIS
time frame: Up to 12-months post treatment
Aesthetic improvement
time frame: Up to 12-months post treatment

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Medicis Global Service Corporation.