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| Name | Class |
|---|---|
| Q-Med Scandinavia, Inc. | INDUSTRY |
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Safety & tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L) while correcting wrinkles in the area around your nose.
A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane and Restylane with Lidocaine | Experimental | This is a split-face design injecting both Restylane and Restylane-L injectable gels, administered once. Each subject received Restylane on one side of the face, and Restylane-L on the other. Subjects were blinded to which side of their face received Restylane or Restylane-L. The study was randomized and treatments successive. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane and Restylane-L | Device | This is a split face design and each subject received both Restylane and Restylane-L. Treatments were double blind, randomized, and successive. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Difference in Pain as Measured by a Visual Analogue Scale | No pain is noted at 0 mm and worst pain is noted at 100 mm. | After Injection on Day of Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Wrinkle Improvement at Day 14 | This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Bank, MD | The Center for Dermatology, Cosmetic and Laser Surgery | Principal Investigator |
| Fredric Brandt, MD | Dermatology Research Institute LLC | Principal Investigator |
| Robert Weiss, MD | Maryland Laser Skin and Vein Institute | Principal Investigator |
| Ron Staugaard | Medicis Pharmaceutical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Research Institute LLC | Coral Gables | Florida | 33146 | United States | ||
| Maryland Laser Skin and Vein Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Restylane | Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 14 days after treatment when compared to baseline |
| Hunt Valley |
| Maryland |
| 21030 |
| United States |
| The Center for Dermatology, Cosmetic and Laser Surgery | Mount Kisco | New York | 10549 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Restylane | Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Treatment Difference in Pain as Measured by a Visual Analogue Scale | No pain is noted at 0 mm and worst pain is noted at 100 mm. | This is a split-face design. Restylane and Restylane with Lidocaine was injected to different sides of the subject's face. A total of 60 subjects received both products. The study evaluated which side of the face had less pain, as measured by the Visual Analogue Scale (VAS). | Posted | Mean | Standard Deviation | Scores on a VAS Scale | After Injection on Day of Treatment | Scores on a Scale | Participants |
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| Secondary | Wrinkle Improvement at Day 14 | This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment. | Posted | Number | participants | 14 days after treatment when compared to baseline |
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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 | Restylane-L Side of Face | Restylane with Lidocaine gel(Restylane-L) side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable). | 0 | 60 | 46 | 60 | ||
| EG001 | Restylane Side of Face | The Restylane gel side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable). | 0 | 60 | 46 | 60 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ecchymosis | Vascular disorders |
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| Edema | General disorders |
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| Erythema | General disorders |
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| Tenderness | General disorders |
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| Pain | General disorders |
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| Pruitis | General disorders |
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| Papule | General disorders |
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| Vasospasm | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ron Staugaard | Medicis | 480-291-5652 | rstaugaard@medicis.com |
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