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| Name | Class |
|---|---|
| Q-Med Scandinavia, Inc. | INDUSTRY |
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Safety study that compares Perlane to Perlane with Lidocaine while correcting wrinkles in the area around your nose.
This is a split-face design. All 60 subjects receive Perlane on one side of their face, and Perlane-L on the other. Subjects and the investigator is blinded to which side of face receives which product. These are one time injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perlane and Perlane-L | Other | This is a split-face design injecting both Perlane and Perlane-L injectable gels, administered once. Each subject received Perlane-L on one side of the face, and Perlane on the other. Subjects were blinded to which side of their face receive Perlane or Perlane-L. The study was randomized and treatments successive. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perlane and Perlane-L | Device | This is a split face design and each subject received both Perlane-L and Perlane. Treatments were blinded, randomized, and successive. |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm | After Injection on Day of Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Showing 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 |
|---|---|---|
| Mary Sanstead | Medicis Global Pharmaceutical | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coral Gables | Florida | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Perlane-L and Perlane | Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 14 days after treatment when compared to baseline |
| Hunt Valley |
| Maryland |
| United States |
| Mount Cisco | New York | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Perlane and Perlane-L | Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other. |
| 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 | ||||||||||||||
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| 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 VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm | This is a split-face design. Perlane and Perlane with Lidocaine was applied to different sides of the subject's face. A total of 60 subjects received both products. The study evaluated which side of the face has less pain, as measured by the Visual Analogue Scale (VAS). Least pain on VAS scale is at 0 mm mark and worst pain is 100 mm mark. | Posted | Number | 95% Confidence Interval | Participants | After Injection on Day of Treatment |
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| Secondary | Number of Subjects Showing 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 | Perlane-L | Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%. | 0 | 60 | 60 | 60 | ||
| EG001 | Perlane | Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%. | 0 | 60 | 60 | 60 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising | General disorders |
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| Redness | General disorders |
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| Swelling | General disorders |
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| Pain | General disorders |
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| Tenderness | General disorders |
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| Itching | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Sanstead | Medicis | 480-291-5926 | msanstead@medicis.com |
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