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
  Purpose

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.


Condition Intervention Phase
Facial Wrinkles
Device: CosmoDerm1
Device: Belotero Soft
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Further study details as provided by Merz Pharmaceuticals, LLC:

Primary Outcome Measures:
  • The severity of the facial wrinkle [ Time Frame: 2 weeks and 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Investigator and subject assessments [ Time Frame: 2 weeks and 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 64
Study Start Date: November 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Belotero Soft
Dermal Filler
Other Name: Belotero Soft
Active Comparator: CosmoDerm1 Device: CosmoDerm1
CosmoDerm1 is a single use syringe, injected into the mid dermal layer.
Other Name: CosmoDerm1

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT00877279

Locations
United States, California
Skin Care & Laser Physicians of Beverly Hills
Los Angeles, California, United States, 90069
Maas Clinic
San Francisco, California, United States, 94115
United States, Connecticut
Savin Dermatology Center
New Haven, Connecticut, United States, 06511
United States, Louisiana
William Coleman, III, MD
Metairie, Louisiana, United States, 70006
United States, New York
Dermatology Surgery and Laser Center
White Plains, New York, United States, 10604
Sponsors and Collaborators
Merz Pharmaceuticals, LLC
Investigators
Principal Investigator: Rhoda Narins, MD Dermatology Surgery and Laser Center
  More Information

No publications provided

Responsible Party: Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT00877279     History of Changes
Other Study ID Numbers: MUS 90028-0717/1
Study First Received: April 3, 2009
Last Updated: October 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merz Pharmaceuticals, LLC:
Facial wrinkles
Nasolabial folds

ClinicalTrials.gov processed this record on September 16, 2014