Safety/Efficacy Study of Restylane® in Lip Augmentation

December 22, 2011 updated by: Medicis Global Service Corporation

A Randomized, Evaluator-Blinded, No-Treatment-Controlled Study of the Effectiveness and Safety of Restylane® in the Augmentation of Soft Tissue Fullness of the Lips

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • Call For Information
      • San Francisco, California, United States, 94117
        • Call For Information
      • Santa Monica, California, United States, 90404
        • Call For Information
    • Connecticut
      • New Haven, Connecticut, United States, 06511-5409
        • Call For Information
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Call For Information
      • Miami Beach, Florida, United States, 33140
        • Call For Information
    • Maryland
      • Hunt valley, Maryland, United States, 21030
        • Call For Information
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States, 02467
        • Call For Information
    • Michigan
      • Clinton Twp., Michigan, United States, 78038
      • Warren, Michigan, United States, 48088
        • Call For Information
    • New York
      • Mount Kisco, New York, United States, 10549
        • Call For Information
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Call For Information

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment
Restylane® Treatment
Device: Restylane®
Restylane® injections in the lips
NO_INTERVENTION: Non-Treatment
Non-Treatment Arm
Device: Non-Treatment
Non- Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Response
Time Frame: Baseline and at 8 weeks
Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at week 8 as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full.
Baseline and at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Response
Time Frame: Baseline and at weeks 12, 16, 20 and 24
Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at post-baseline time points as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full.
Baseline and at weeks 12, 16, 20 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medicis Global Service Corporation

Investigators

  • Study Chair: Heather Corey, MBA, Medicis Global Service Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

July 7, 2009

First Submitted That Met QC Criteria

July 7, 2009

First Posted (ESTIMATE)

July 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 30, 2012

Last Update Submitted That Met QC Criteria

December 22, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • MA-1300-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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