Safety/Efficacy Study of Restylane® in Lip Augmentation
This study has been completed.
Sponsor:
Medicis Global Service Corporation
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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00935272
Locations
| United States, California | |
| Call for Information | |
| 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 May 23, 2013