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

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.

Condition or disease Intervention/treatment Phase
Facial Wrinkles Device: CosmoDerm1 Device: Belotero Soft Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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.
Study Start Date : November 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Arm Intervention/treatment
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

Active Comparator: CosmoDerm1 Device: CosmoDerm1
CosmoDerm1 is a single use syringe, injected into the mid dermal layer.

Primary Outcome Measures :
  1. The severity of the facial wrinkle [ Time Frame: 2 weeks and 4 weeks ]

Secondary Outcome Measures :
  1. Investigator and subject assessments [ Time Frame: 2 weeks and 4 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00877279

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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 North America, Inc.
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Principal Investigator: Rhoda Narins, MD Dermatology Surgery and Laser Center
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Responsible Party: Merz North America, Inc. Identifier: NCT00877279    
Other Study ID Numbers: MUS 90028-0717/1
First Posted: April 7, 2009    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: October 2013
Keywords provided by Merz North America, Inc.:
Facial wrinkles
Nasolabial folds
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes