To determine the safety and effectiveness of Restylane® when used for lip augmentation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
Restylane® injections in the lips
Non- Treatment
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San Diego, California, United States
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San Francisco, California, United States
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Santa Monica, California, United States
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.
Time frame: Baseline and at 8 weeks
Percentage of Participants With a Response
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.
Time frame: Baseline and at weeks 12, 16, 20 and 24
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New Haven, Connecticut, United States
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Coral Gables, Florida, United States
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Miami Beach, Florida, United States
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Hunt Valley, Maryland, United States
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Chestnut Hill, Massachusetts, United States
Unnamed facility
Clinton Twp., Michigan, United States
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Warren, Michigan, United States
...and 2 more locations