Safety/Efficacy Study of Restylane® in Lip Augmentation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medicis Global Service Corporation
ClinicalTrials.gov Identifier:
NCT00935272
First received: July 7, 2009
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention
Lip Augmentation
Device: Restylane®
Device: Non-Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Medicis Global Service Corporation:

Primary Outcome Measures:
  • Percentage of Participants With Response [ Time Frame: Baseline and at 8 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants With a Response [ Time Frame: Baseline and at weeks 12, 16, 20 and 24 ] [ Designated as safety issue: No ]
    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.


Enrollment: 180
Study Start Date: July 2009
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Restylane® Treatment
Device: Restylane®
Restylane® injections in the lips
No Intervention: Non-Treatment
Non-Treatment Arm
Device: Non-Treatment
Non- Treatment

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935272

Locations
United States, California
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San Diego, California, United States, 92123
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San Francisco, California, United States, 94117
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Santa Monica, California, United States, 90404
United States, Connecticut
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New Haven, Connecticut, United States, 06511-5409
United States, Florida
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Coral Gables, Florida, United States, 33146
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Miami Beach, Florida, United States, 33140
United States, Maryland
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Hunt valley, Maryland, United States, 21030
United States, Massachusetts
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Chestnut Hill, Massachusetts, United States, 02467
United States, Michigan
Clinton Twp., Michigan, United States, 78038
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Warren, Michigan, United States, 48088
United States, New York
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Mount Kisco, New York, United States, 10549
United States, North Carolina
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Chapel Hill, North Carolina, United States, 27517
Sponsors and Collaborators
Medicis Global Service Corporation
Investigators
Study Chair: Heather Corey, MBA Medicis Global Service Corporation
  More Information

No publications provided

Responsible Party: Medicis Global Service Corporation
ClinicalTrials.gov Identifier: NCT00935272     History of Changes
Other Study ID Numbers: MA-1300-15
Study First Received: July 7, 2009
Results First Received: November 2, 2011
Last Updated: December 22, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 28, 2014