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

COMPLETEDPHASE3

Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero®.

A Randomized, Blinded, Controlled, Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero®, After Mid-to-Deep Dermal Implantation for Correction of Moderate to Severe Facial Wrinkles

NCT00876265•Merz North America, Inc.

View on ClinicalTrials.gov

Summary

This was a study to find out how an investigational product, Belotero, compares to a second product in people with facial wrinkles, such as nasolabial folds. Nasolabial folds are wrinkles on the face that go from the outside of the nostrils to the edges of the mouth. Additionally, this study determined Belotero is safe and tolerable and corrects facial wrinkles, such as nasolabial folds.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subjects reviewed and signed a statement of Informed Consent and a HIPAA authorization prior to initiating any study-specific procedures. In addition, subjects were asked to provide a separate release for use of their photographs in publications. Subjects could refuse the photo release without jeopardizing their eligibility to participate in the study.
•2. Subjects were 18 - 75 years of age, and of any race or sex.
•3. Female subjects were postmenopausal for at least 1 year, had a hysterectomy, or had a tubal ligation; or, if of childbearing potential, agreed to use an approved method of birth control throughout the study (i.e., oral/systemic contraceptives, intrauterine device \[IUD\], or spermicide in combination with a barrier method of contraception), were abstinent, or were in a monogamous relationship with a vasectomized partner; and had a negative urine pregnancy test at the screening visit.
•4. Subjects had bilateral nasolabial folds with a severity score of 2 or 3 on the wrinkle SRS assessed by the blinded evaluator.
•5. Each subject had an adequate understanding of the language (spoken and written English or Spanish) and was willing to comply with the study requirements.

Exclusion Criteria

•1. A personal history of allergic/anaphylactic reactions including hypersensitivity to local anesthetics (eg, lidocaine, etc), HA preparations, and/or gram-positive bacterial protein.
•2. A known history of keloids or bleeding disorders.
•3. An active inflammatory process in the nasolabial fold area (skin eruptions such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, psoriasis, neurodermatitis, or any other active skin disease) or severe scarring that might interfere with study assessments.
•4. Women who were pregnant, planning to become pregnant during the study, or who were breast-feeding.
•5. Subjects who planned to undergo major facial surgery during the course of the study (eg, rhinoplasty \[with or without implant\], facelift, congenital defect repair, etc).
•6. Subjects with clinically important disease, as judged by the investigator, within 3 months of the study (eg, significant laboratory test abnormalities, myocardial infarct, stroke, cancer, connective tissue diseases \[scleroderma, systemic lupus erythematous\], systemic infection, uncontrolled diabetes, etc.), including those with medical conditions that might require the use of immunosuppressive medications during the trial (eg, severe, uncontrolled asthma, rheumatoid arthritis, autoimmune diseases, etc).
•7. Severe physical, neurological or mental disease.
•8. Excessive facial hair that might interfere with the evaluation of the wrinkle assessments.
•9. Any systemic or dermatologic disorder, which, in the opinion of the investigator,would interfere with the study results or increase the risk of adverse events (AEs).
•10. Subjects who had used exclusionary medications/treatments.
+1 more criteria

Locations (6)

Total Skin and Beauty Dermatology Center

Birmingham, Alabama, United States

Skin Care & Laser Physicians of Beverly Hills

Los Angeles, California, United States

Maas Clinic

San Francisco, California, United States

Savin Dermatology

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

December 1, 2006

Primary Completion Date

July 1, 2007

Completion Date

December 1, 2008

Last Updated

April 26, 2013

Enrollment

118

ACTUAL participants

Conditions

Facial Wrinkles

Interventions

Belotero

DEVICE

Zyplast

DEVICE

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

NCT06657365

Facial WrinklesAnti-Aging+3 more

View study

COMPLETEDPHASE2/PHASE3

Cryo-Touch II for the Treatment of Wrinkles

NCT01167140

Facial Wrinkles

View study

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: April 26, 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 Effectiveness of Dermal Filler, Belotero®.

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)