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Multicenter Study of the Safety and Efficacy of Dermal Filler, Belotero® Soft

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: NCT00877279
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : November 15, 2013
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc.

Tracking Information
First Submitted Date  ICMJE April 3, 2009
First Posted Date  ICMJE April 7, 2009
Last Update Posted Date November 15, 2013
Study Start Date  ICMJE November 2007
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2009)
The severity of the facial wrinkle [ Time Frame: 2 weeks and 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2009)
Investigator and subject assessments [ Time Frame: 2 weeks and 4 weeks ]
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 Multicenter Study of the Safety and Efficacy of Dermal Filler, Belotero® Soft
Official Title  ICMJE A Randomized,Blinded,Controlled,Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero® Soft, After Superficial to Mid Dermal Implantation for Correction of Mild Facial Wrinkles Over 4 Weeks.
Brief Summary This study is to determine the safety and effectiveness of Belotero® Soft compared to active comparator in the correction of mild facial wrinkles, such as nasolabial folds.
Detailed Description The purpose of the study is to see if Belotero® Soft is safe and effective for correction of mild facial wrinkles, such as nasolabial folds. The second objective of the study is to see if Belotero® Soft works better than the active comparator. Subjects will receive Belotero® Soft injection to one side of the face and the active comparator to the other side of the face.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Facial Wrinkles
Intervention  ICMJE
  • Device: CosmoDerm1
    CosmoDerm1 is a single use syringe, injected into the mid dermal layer.
  • Device: Belotero Soft
    Dermal Filler
Study Arms  ICMJE
  • Experimental: Belotero® Soft
    Comparator will be given into the opposite side of the face that Belotero® Soft was administered for facial wrinkles, such as nasolabial folds.
    Intervention: Device: Belotero Soft
  • Active Comparator: CosmoDerm1
    Intervention: Device: CosmoDerm1
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 Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2009)
64
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must have bilateral facial wrinkles, such as nasolabial folds

Exclusion Criteria:

  • Other nasolabial fold correction within 6 months prior to study entry.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT00877279
Other Study ID Numbers  ICMJE MUS 90028-0717/1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merz North America, Inc.
Study Sponsor  ICMJE Merz North America, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rhoda Narins, MD Dermatology Surgery and Laser Center
PRS Account Merz North America, Inc.
Verification Date October 2013

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