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

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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

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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