Safety/Efficacy Study of Restylane® in Lip Augmentation
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
1 other identifier
interventional
180
1 country
12
Brief Summary
To determine the safety and effectiveness of Restylane® when used for lip augmentation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2009
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 7, 2009
CompletedFirst Posted
Study publicly available on registry
July 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
January 30, 2012
CompletedJanuary 30, 2012
December 1, 2011
11 months
July 7, 2009
November 2, 2011
December 22, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Response
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 Outcomes (1)
Percentage of Participants With a Response
Baseline and at weeks 12, 16, 20 and 24
Study Arms (2)
Treatment
EXPERIMENTALRestylane® Treatment
Non-Treatment
NO INTERVENTIONNon-Treatment Arm
Interventions
Eligibility Criteria
You may qualify if:
- Must meet established lip fullness criteria
You may not qualify if:
- Allergic to injectable hyaluronic acid, local topical anesthetics or nerve blocking agents; Conditions/procedures that could interfere with lip fullness evaluations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
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San Diego, California, 92123, United States
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San Francisco, California, 94117, United States
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Santa Monica, California, 90404, United States
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New Haven, Connecticut, 06511-5409, United States
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Coral Gables, Florida, 33146, United States
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Miami Beach, Florida, 33140, United States
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Hunt Valley, Maryland, 21030, United States
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Chestnut Hill, Massachusetts, 02467, United States
Unknown Facility
Clinton Twp., Michigan, 78038, United States
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Warren, Michigan, 48088, United States
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Mount Kisco, New York, 10549, United States
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Chapel Hill, North Carolina, 27517, United States
Results Point of Contact
- Title
- Heather M Corey
- Organization
- Medicis Global Services
Study Officials
- STUDY CHAIR
Heather Corey, MBA
Medicis Global Service Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2009
First Posted
July 9, 2009
Study Start
July 1, 2009
Primary Completion
June 1, 2010
Study Completion
July 1, 2010
Last Updated
January 30, 2012
Results First Posted
January 30, 2012
Record last verified: 2011-12