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

Facial Wrinkles Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877279
• Other study ID #: MUS 90028-0717/1
• Status: Completed
• Phase: Phase 3
• First received: April 3, 2009
• Last updated: October 23, 2013
• Start date: November 2007
• Est. completion date: March 2008

Study information

• Verified date: October 2013
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Facial Wrinkles

Intervention

Device:
• CosmoDerm1
CosmoDerm1 is a single use syringe, injected into the mid dermal layer.
• Belotero Soft
Dermal Filler

Locations

Country	Name	City	State
United States	Skin Care & Laser Physicians of Beverly Hills	Los Angeles	California
United States	William Coleman, III, MD	Metairie	Louisiana
United States	Savin Dermatology Center	New Haven	Connecticut
United States	Maas Clinic	San Francisco	California
United States	Dermatology Surgery and Laser Center	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The severity of the facial wrinkle		2 weeks and 4 weeks	Yes
Secondary	Investigator and subject assessments		2 weeks and 4 weeks	Yes