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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01565915
Recruitment Status : Unknown
Verified August 2013 by Medicis Global Service Corporation.
Recruitment status was:  Active, not recruiting
First Posted : March 29, 2012
Last Update Posted : August 21, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine if Perlane-L is safe in increasing cheek volume.

Condition or disease Intervention/treatment
Facial Volume Device: Perlane-L Other: Non-treatment

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Facial fullness using midface scale [ Time Frame: Week 8 ]
    Change in facial fullness using midface scale.


Secondary Outcome Measures :
  1. Facial fullness using the midface scale [ Time Frame: Up to 12-months post treatment ]
    Change in facial fullness using midface scale.

  2. 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)

  3. Aesthetic improvement [ Time Frame: Up to 12-months post treatment ]
    A subjective assessment of aesthetic improvement post baseline


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565915


Locations
United States, California
Beverly Hills, California, United States
San Francisco, California, United States
Vista, California, United States
United States, Florida
Aventura, Florida, United States
Coral Gables, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Maryland
Hunt Valley, Maryland, United States
United States, Massachusetts
Chestnut Hill, Massachusetts, United States
United States, New York
Mount Kisco, New York, United States
New York, New York, United States
United States, Oregon
Eugene, Oregon, United States
Sponsors and Collaborators
Medicis Global Service Corporation
More Information

Responsible Party: Medicis Global Service Corporation
ClinicalTrials.gov Identifier: NCT01565915     History of Changes
Other Study ID Numbers: MA-1400-05
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: August 21, 2013
Last Verified: August 2013