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

Merz Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Facial Wrinkles

Treatments: Device: Belotero Soft; Device: CosmoDerm1

Study type: Interventional

Funder types: Industry

Identifiers

NCT00877279

MUS 90028-0717/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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64 participants in 2 patient groups

Belotero® Soft

Experimental group

Description:

Comparator will be given into the opposite side of the face that Belotero® Soft was administered for facial wrinkles, such as nasolabial folds.

Treatment:

Device: Belotero Soft

CosmoDerm1

Active Comparator group

Treatment:

Device: CosmoDerm1