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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medicis Global Service Corporation
ClinicalTrials.gov Identifier:
NCT01565915
First received: March 12, 2012
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Medicis Global Service Corporation:

Primary Outcome Measures:
  • Facial fullness using midface scale [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Change in facial fullness using midface scale.


Secondary Outcome Measures:
  • Facial fullness using the midface scale [ Time Frame: Up to 12-months post treatment ] [ Designated as safety issue: No ]
    Change in facial fullness using midface scale.

  • Subject satisfaction using the GAIS [ Time Frame: Up to 12-months post treatment ] [ Designated as safety issue: No ]
    Compare treatment satisfaction as compared to no treatment, on the Global Aesthetic Improvement Scale (GAIS)

  • Aesthetic improvement [ Time Frame: Up to 12-months post treatment ] [ Designated as safety issue: No ]
    A subjective assessment of aesthetic improvement post baseline


Enrollment: 221
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Medicis Global Service Corporation
ClinicalTrials.gov Identifier: NCT01565915     History of Changes
Other Study ID Numbers: MA-1400-05
Study First Received: March 12, 2012
Last Updated: August 20, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 21, 2014