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

Phase 3

Completed

• Conditions: Facial Wrinkles
• Interventions: Device: Belotero Soft; Device: CosmoDerm1

• Registration Number: NCT00877279
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-11
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2009-04-03
• Study First Submitted QC: 2009-04-06
• Study First Posted: 2009-04-07
• Disposition First Submitted: 2011-10-12
• Disposition First Submitted QC: 2011-10-12
• Disposition First Posted: 2011-10-21
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-23
• Last Update Posted: 2013-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Belotero® Soft	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.
CosmoDerm1	CosmoDerm1	-

Primary Outcome Measures

Name	Time	Method
The severity of the facial wrinkle	2 weeks and 4 weeks

Secondary Outcome Measures

Name	Time	Method
Investigator and subject assessments	2 weeks and 4 weeks

Trial Locations

Locations (5)

Savin Dermatology Center; 🇺🇸 New Haven, Connecticut, United States

Skin Care & Laser Physicians of Beverly Hills; 🇺🇸 Los Angeles, California, United States

William Coleman, III, MD; 🇺🇸 Metairie, Louisiana, United States

Maas Clinic; 🇺🇸 San Francisco, California, United States

Dermatology Surgery and Laser Center; 🇺🇸 White Plains, New York, United States