Lip Augmentation
Conditions
Brief summary
To determine the safety and effectiveness of Restylane® when used for lip augmentation.
Interventions
DEVICERestylane®
Restylane® injections in the lips
DEVICENon-Treatment
Non- Treatment
Sponsors
Medicis Global Service Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Response | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Response | 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. |
Countries
United States
Participant flow
Recruitment details
Date of first enrollment: July 20, 2009 Date last subject completed: June 1, 2010 180 subjects enrolled from 12 investigational centers
Pre-assignment details
Subjects with Fitzpatrick Skin Types I, II or III (lighter skin types) needed both lips to be assessed as very thin or thin to meet enrollment criteria. Subjects with Fitzpatrick Skin Types IV, V or VI (darker skin types) need at least one lip to be assessed as very thin or thin to meet enrollment criteria.
Participants by arm
| Arm | Count |
|---|---|
| Treatment With Restylane Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion. | 135 |
| No Treatment Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis | 45 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 3 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 2 |
Baseline characteristics
| Characteristic | No Treatment | Treatment With Restylane | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 133 Participants | 177 Participants |
| Age Continuous | 47.2 years STANDARD_DEVIATION 10.9 | 47.8 years STANDARD_DEVIATION 10.5 | 47.6 years STANDARD_DEVIATION 10.6 |
| Region of Enrollment United States | 45 participants | 135 participants | 180 participants |
| Sex: Female, Male Female | 45 Participants | 134 Participants | 179 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 149 / 172 | 5 / 45 | 60 / 93 |
| serious Total, serious adverse events | 4 / 135 | 1 / 45 | 0 / 93 |
Outcome results
Primary
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
Population: Analysis was ITT; Sample size based upon a one-sided Fisher's Exact test with alpha = 0.05; Subjects with a missing Blinded Evaluator assessment as Week 8 were imputed using the hot deck method
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With Restylane | Percentage of Participants With Response | 92.6 Percentage of Participants |
| No Treatment | Percentage of Participants With Response | 28.9 Percentage of Participants |
Secondary
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
Population: For this secondary objective, the pool of participants analyzed was based on 135 from the Intent to Treat population. However the analysis was done with the number of subjects with non-missing data. This number varied for each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment With Restylane | Percentage of Participants With a Response | Week 12 | 90.1 Percent of responders |
| Treatment With Restylane | Percentage of Participants With a Response | Week 20 | 75.0 Percent of responders |
| Treatment With Restylane | Percentage of Participants With a Response | Week 16 | 84.2 Percent of responders |
| Treatment With Restylane | Percentage of Participants With a Response | Week 24 | 69.6 Percent of responders |
| No Treatment | Percentage of Participants With a Response | Week 16 | 35.9 Percent of responders |
| No Treatment | Percentage of Participants With a Response | Week 12 | 36.8 Percent of responders |
| No Treatment | Percentage of Participants With a Response | Week 24 | 36.8 Percent of responders |
| No Treatment | Percentage of Participants With a Response | Week 20 | 33.3 Percent of responders |