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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00877279
First Posted: April 7, 2009
Last Update Posted: November 15, 2013
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.
Information provided by (Responsible Party):
Merz North America, Inc.
April 3, 2009
April 7, 2009
November 15, 2013
November 2007
March 2008   (Final data collection date for primary outcome measure)
The severity of the facial wrinkle [ Time Frame: 2 weeks and 4 weeks ]
Same as current
Complete list of historical versions of study NCT00877279 on ClinicalTrials.gov Archive Site
Investigator and subject assessments [ Time Frame: 2 weeks and 4 weeks ]
Same as current
Not Provided
Not Provided
 
Multicenter Study of the Safety and Efficacy of Dermal Filler, Belotero® Soft
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.
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Facial Wrinkles
  • Device: CosmoDerm1
    CosmoDerm1 is a single use syringe, injected into the mid dermal layer.
  • Device: Belotero Soft
    Dermal Filler
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
March 2008
March 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00877279
MUS 90028-0717/1
No
Not Provided
Not Provided
Merz North America, Inc.
Merz North America, Inc.
Not Provided
Principal Investigator: Rhoda Narins, MD Dermatology Surgery and Laser Center
Merz North America, Inc.
October 2013

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