Safety/Efficacy Study of Restylane® in Lip Augmentation

NCT ID: NCT00935272

Last Updated: 2012-01-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-07-31

Brief Summary

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To determine the safety and effectiveness of Restylane® when used for lip augmentation.

Detailed Description

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Conditions

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Lip Augmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment

Restylane® Treatment

Group Type EXPERIMENTAL

Restylane®

Intervention Type DEVICE

Restylane® injections in the lips

Non-Treatment

Non-Treatment Arm

Group Type NO_INTERVENTION

Non-Treatment

Intervention Type DEVICE

Non- Treatment

Interventions

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Restylane®

Restylane® injections in the lips

Intervention Type DEVICE

Non-Treatment

Non- Treatment

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Must meet established lip fullness criteria

Exclusion Criteria

* Allergic to injectable hyaluronic acid, local topical anesthetics or nerve blocking agents; Conditions/procedures that could interfere with lip fullness evaluations
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medicis Global Service Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heather Corey, MBA

Role: STUDY_CHAIR

Medicis Global Service Corporation

Locations

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Call for Information

San Diego, California, United States

Site Status

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San Francisco, California, United States

Site Status

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Santa Monica, California, United States

Site Status

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New Haven, Connecticut, United States

Site Status

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Coral Gables, Florida, United States

Site Status

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Miami Beach, Florida, United States

Site Status

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Hunt Valley, Maryland, United States

Site Status

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Chestnut Hill, Massachusetts, United States

Site Status

Clinton Twp., Michigan, United States

Site Status

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Warren, Michigan, United States

Site Status

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Mount Kisco, New York, United States

Site Status

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Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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MA-1300-15

Identifier Type: -

Identifier Source: org_study_id

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