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Multicenter Study of the Safety and Efficacy of Dermal Filler, Belotero® Soft | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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.

NCT00877279•Merz North America, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

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.

Locations (5)

Skin Care & Laser Physicians of Beverly Hills

Los Angeles, California, United States

Maas Clinic

San Francisco, California, United States

Savin Dermatology Center

New Haven, Connecticut, United States

William Coleman, III, MD

Metairie, Louisiana, United States

Dermatology Surgery and Laser Center

White Plains, New York, United States

Key Dates

Start Date

November 1, 2007

Primary Completion Date

March 1, 2008

Completion Date

March 1, 2008

Last Updated

November 15, 2013

Enrollment

ACTUAL participants

Conditions

Facial Wrinkles

Interventions

CosmoDerm1

DEVICE

Belotero Soft

DEVICE

Safety and Efficacy Evaluation of the Monopolar Radiofrequency Device for the Improvement of Facial Wrinkles

NCT06657365

Facial WrinklesAnti-Aging+3 more

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COMPLETEDPHASE2/PHASE3

Cryo-Touch II for the Treatment of Wrinkles

NCT01167140

Facial Wrinkles

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 15, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Safety and Efficacy Evaluation of the Monopolar Radiofrequency Device for the Improvement of Facial Wrinkles

Cryo-Touch II for the Treatment of Wrinkles

The Use of J-Plasma® for Dermal Resurfacing

Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers

A Study to Compare the Safety and Effectiveness of a Non-FDA Approved Device Dermal Gel Extra (DGE) and an FDA Approved Device for the Correction of Nasolabial Folds (NLFs)

A Study to Compare Subject Comfort During and After Injections With the Study Products and the Safety of the Non-FDA Approved Product for the Correction of Nasolabial Folds (NLFs)