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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):
Medicis Global Service Corporation

Tracking Information
First Submitted Date  ICMJE March 12, 2012
First Posted Date  ICMJE March 29, 2012
Last Update Posted Date August 21, 2013
Study Start Date  ICMJE March 2012
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
Facial fullness using midface scale [ Time Frame: Week 8 ]
Change in facial fullness using midface scale.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
  • Facial fullness using the midface scale [ Time Frame: Up to 12-months post treatment ]
    Change in facial fullness using midface scale.
  • 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)
  • Aesthetic improvement [ Time Frame: Up to 12-months post treatment ]
    A subjective assessment of aesthetic improvement post baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Perlane-L in the Correction of Midface Volume Deficit
Official Title  ICMJE Not Provided
Brief Summary The purpose of this study is to determine if Perlane-L is safe in increasing cheek volume.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Facial Volume
Intervention  ICMJE
  • Device: Perlane-L
    Perlane-L Injection in the midface
  • Other: Non-treatment
    Non-treatment Arm
Study Arms  ICMJE
  • Experimental: Perlane-L
    Perlane-L treatment
    Intervention: Device: Perlane-L
  • Sham Comparator: Non-Treatment
    Non-Treatment Arm
    Intervention: Other: Non-treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 13, 2013)
221
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2012)
200
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01565915
Other Study ID Numbers  ICMJE MA-1400-05
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medicis Global Service Corporation
Study Sponsor  ICMJE Medicis Global Service Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medicis Global Service Corporation
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP