NCT00877279

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Merz North America, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Facial Wrinkles

Interventions

Type	Name	Description
DEVICE	CosmoDerm1	CosmoDerm1 is a single use syringe, injected into the mid dermal layer.
DEVICE	Belotero Soft	Dermal Filler

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2009-04-07
• Last updated: 2013-11-15

Locations

5 sites across 1 country: United States