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

August 20, 2013 updated by: Medicis Global Service Corporation
The purpose of this study is to determine if Perlane-L is safe in increasing cheek volume.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States
      • San Francisco, California, United States
      • Vista, California, United States
    • Florida
      • Aventura, Florida, United States
      • Coral Gables, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Maryland
      • Hunt Valley, Maryland, United States
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States
    • New York
      • Mount Kisco, New York, United States
      • New York, New York, United States
    • Oregon
      • Eugene, Oregon, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perlane-L
Perlane-L treatment
Device: Perlane-L
Perlane-L Injection in the midface
Sham Comparator: Non-Treatment
Non-Treatment Arm
Other: Non-treatment
Non-treatment Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facial fullness using midface scale
Time Frame: Week 8
Change in facial fullness using midface scale.
Week 8

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medicis Global Service Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

March 12, 2012

First Submitted That Met QC Criteria

March 27, 2012

First Posted (Estimate)

March 29, 2012

Study Record Updates

Last Update Posted (Estimate)

August 21, 2013

Last Update Submitted That Met QC Criteria

August 20, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • MA-1400-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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