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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00877279
First received: April 3, 2009
Last updated: October 23, 2013
Last verified: October 2013

April 3, 2009
October 23, 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Facial Wrinkles
  • Device: CosmoDerm1
    CosmoDerm1 is a single use syringe, injected into the mid dermal layer.
    Other Name: CosmoDerm1
  • Device: Belotero Soft
    Dermal Filler
    Other Name: Belotero Soft
  • 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.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00877279
MUS 90028-0717/1
No
Merz Pharmaceuticals, LLC
Merz Pharmaceuticals, LLC
Not Provided
Principal Investigator: Rhoda Narins, MD Dermatology Surgery and Laser Center
Merz Pharmaceuticals, LLC
October 2013

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