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

NCT ID: NCT00877279

Last Updated: 2013-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-03-31

Brief Summary

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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

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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.

Conditions

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Facial Wrinkles

Keywords

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Facial wrinkles Nasolabial folds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Belotero® Soft

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

Group Type EXPERIMENTAL

Belotero Soft

Intervention Type DEVICE

Dermal Filler

CosmoDerm1

Group Type ACTIVE_COMPARATOR

CosmoDerm1

Intervention Type DEVICE

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

Interventions

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CosmoDerm1

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

Intervention Type DEVICE

Belotero Soft

Dermal Filler

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merz North America, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rhoda Narins, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Surgery and Laser Center

Locations

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Skin Care & Laser Physicians of Beverly Hills

Los Angeles, California, United States

Site Status

Maas Clinic

San Francisco, California, United States

Site Status

Savin Dermatology Center

New Haven, Connecticut, United States

Site Status

William Coleman, III, MD

Metairie, Louisiana, United States

Site Status

Dermatology Surgery and Laser Center

White Plains, New York, United States

Site Status

Countries

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United States

Other Identifiers

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MUS 90028-0717/1

Identifier Type: -

Identifier Source: org_study_id