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To determine the safety and effectiveness of Restylane® when used for lip augmentation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Restylane® Treatment |
|
| Non-Treatment | No Intervention | Non-Treatment Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane® | Device | Restylane® injections in the lips |
| |
| Non-Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather Corey, MBA | Medicis Global Service Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Call for Information | San Diego | California | 92123 | United States | ||
| Call for Information |
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.
Date of first enrollment: July 20, 2009 Date last subject completed: June 1, 2010 180 subjects enrolled from 12 investigational centers
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | No Treatment | Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline and at 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment With Restylane | Safety included post treatment assessment, and assessments at each visit throughout the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Diverticulitis | Infections and infestations | MeDRA | Not related to Restylane as determined by the physician. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather M Corey | Medicis Global Services | 480-291-5981 | hcorey@medicis.com |
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| Device |
Non- Treatment |
|
| Baseline and at weeks 12, 16, 20 and 24 |
| San Francisco |
| California |
| 94117 |
| United States |
| Call for Information | Santa Monica | California | 90404 | United States |
| Call for Information | New Haven | Connecticut | 06511-5409 | United States |
| Call for Information | Coral Gables | Florida | 33146 | United States |
| Call for Information | Miami Beach | Florida | 33140 | United States |
| Call for Information | Hunt Valley | Maryland | 21030 | United States |
| Call for Information | Chestnut Hill | Massachusetts | 02467 | United States |
| Clinton Twp. | Michigan | 78038 | United States |
| Call for Information | Warren | Michigan | 48088 | United States |
| Call for Information | Mount Kisco | New York | 10549 | United States |
| Call for Information | Chapel Hill | North Carolina | 27517 | United States |
| Physician Decision |
|
| Protocol Violation |
|
| BG001 | No Treatment | Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | No Treatment | Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis |
|
|
| 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. | 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. | Posted | Oct 2011 | Number | 95% Confidence Interval | Percent of responders | Baseline and at weeks 12, 16, 20 and 24 |
|
|
|
| 4 |
| 135 |
| 149 |
| 172 |
| EG001 | No Treatment | Safety included post treatment assessment, and assessments at each visit throughout the study. | 1 | 45 | 5 | 45 |
| EG002 | Second Treatment | At Week 24, subjects who were initially randomized to treatment were offered an optional second treatment with Restylane. In addition those randomized to non-treatment were offered their first treatment of Restylane at week 24. The safety from this set was followed to one month after the treatment. | 0 | 93 | 60 | 93 |
|
| Transient Ischemic Attack | Nervous system disorders | Probably not related to Restylane as determined by the physician. |
|
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | Not related to Restylane as determined by the physician. |
|
| Streptococcus Pneumonia | Infections and infestations | Not related to Restylane as determined by the physician. |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Not related to Restylane as determined by the physician. |
|
| Swelling | General disorders |
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| Tenderness | General disorders |
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| Nasopharyngitis | Infections and infestations |
|
| Contusion | Injury, poisoning and procedural complications |
|
| Headache | Nervous system disorders |
|
| Erythema | Skin and subcutaneous tissue disorders |
|
| Skin Exfoliation | Skin and subcutaneous tissue disorders |
|
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| Week 20 |
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| Week 24 |
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