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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00877279

Enrollment

Registered

2009-04-07

Start date

2007-11-30

Completion date

2008-03-31

Last updated

2013-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Wrinkles

Keywords

Facial wrinkles, Nasolabial folds

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.

Interventions

DEVICECosmoDerm1

CosmoDerm1 is a single use syringe, injected into the mid dermal layer.

DEVICEBelotero Soft

Dermal Filler

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
The severity of the facial wrinkle	2 weeks and 4 weeks

Secondary

Measure	Time frame
Investigator and subject assessments	2 weeks and 4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026