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The purpose of this study is to determine whether the Matrix RF applicator is effective in the treatment of facial skin texture and wrinkle reduction.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional RF treatment with Matrix RF applicator | Device | 3 treatments, single pass, 2-50J |
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| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Fine Lines | Improvement of fine lines (wrinkles) assessed per anatomical area treated based on Improvement Scale: 0-4 where higher scores indicate a better outcome. Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up | 4 week follow up after last treatment |
| Improvement in Smoothness | Smoothness of anatomical treated area assessed based on Improvement Scale 0-4.Where higher scores indicate a better outcome. Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up | 4 weeks follow up post last treatment |
| Improvement in Brightness | Assess the improvement in brightness of the treated anatomical area using Improvement Scale where higher scores indicate a better outcome. Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up | 4 week follow up post last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Dermatology | Lincolnshire | Illinois | 60069 | United States | ||
| Laser and Dermatology Surgery Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Treatment group- undergo 3 treatments every 4-6 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Chesterfield |
| Missouri |
| 63017 |
| United States |
| Laserderm | Ottawa | Ontario | K1Z 1G3 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Treatment group- undergo 3 treatments every 4-6 weeks |
| 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 | Improvement in Fine Lines | Improvement of fine lines (wrinkles) assessed per anatomical area treated based on Improvement Scale: 0-4 where higher scores indicate a better outcome. Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up | Per protocol each defined anatomical area treated was assessed for improvement according to Improvement Scale- 0-4 | Posted | Mean | Standard Deviation | Scores on a scale | 4 week follow up after last treatment | Fine Lines | Participants |
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| Primary | Improvement in Smoothness | Smoothness of anatomical treated area assessed based on Improvement Scale 0-4.Where higher scores indicate a better outcome. Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up | Analysis was per protocol, each area treated was graded on its improvement regarding the smoothness of the skin | Posted | Mean | Standard Deviation | Scores on a scale | 4 weeks follow up post last treatment | Smoothness | Participants |
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| Primary | Improvement in Brightness | Assess the improvement in brightness of the treated anatomical area using Improvement Scale where higher scores indicate a better outcome. Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up | Per protocol, each anatomical area treated was assessed for skin brightness using the Improvement Scale of 0-4 where 0= 0%, 1= 1-25%, 2=26-50%, 3=51-75%, 4= 76-100% based on before and photographs. Maximum value grade is 4 and the minimum value grade is 0. | Posted | Mean | Standard Deviation | Scores on a scale | 4 week follow up post last treatment | Brightness | Participants |
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Adverse event data was collected for the duration of the study, up to 5 months
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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 | Treatment group- undergo 3 treatments every 4-6 weeks | 0 | 63 | 0 | 63 |
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PI is under a general confidentiality agreement and must have prior written approval by the Sponsor prior to publishing the study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hanit Brenner-Lavie | Syneron Medical Ltd | 972-73-244-2200 | 581 | hanitb@syneron.com |
| Smoothness |
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| Brightness |
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