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This study will evaluate the safety and efficacy of the Excel V 532 nm KTP laser for the treatment of dyschromia of the neck and/or chest (poikiloderma of Civatte).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 532 nm KTP laser treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 532 nm KTP laser | Device | Laser treatment sessions on the neck and/or chest |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity Assessment Score | Change in Physician's Severity Assessment score based on blinded assessment of subject photographs by a panel of independent dermatologists. Blinded Physician's Severity Assessment (min=1;max=4); Higher scores mean worse values | 24 weeks |
| Physician's Global Assessment (Blinded) | Before and after subject photographs were presented to a panel of independent dermatologists. The panel was blinded to treatment parameters and the photograph time points. Each dermatologist was asked to select the baseline photograph and then rate improvement in Poikiloderma of Civatte in the post-treatment photograph using a 5-point improvement scale. Physician's Global Assessment (min= -1; max=4) Higher scores mean better outcome | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zel Skin and Laser Specialists | Edina | Minnesota | 55424 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 532 nm KTP Laser Treatment | 532 nm KTP laser: Laser treatment sessions to neck and/or chest. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 532 nm KTP Laser Treatment | 532 nm KTP laser: Two laser treatment sessions to neck and/or chest. 6 weeks apart. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Severity Assessment Score | Change in Physician's Severity Assessment score based on blinded assessment of subject photographs by a panel of independent dermatologists. Blinded Physician's Severity Assessment (min=1;max=4); Higher scores mean worse values | Only 5 subjects were treated and then assessed at 24 weeks in their upper chest area | Posted | Mean | Standard Deviation | score on a scale | 24 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 | 532 nm KTP Laser Treatment | 532 nm KTP laser: Laser treatment sessions to neck or chest |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margot Doucette | Cutera | 415-657-5518 | mdoucette@cutera.com |
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| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D013684 | Telangiectasis |
| D010787 | Photosensitivity Disorders |
| D004890 | Erythema |
| D017495 | Hyperpigmentation |
| D017496 | Hypopigmentation |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Physician's Global Assessment (Blinded) | Before and after subject photographs were presented to a panel of independent dermatologists. The panel was blinded to treatment parameters and the photograph time points. Each dermatologist was asked to select the baseline photograph and then rate improvement in Poikiloderma of Civatte in the post-treatment photograph using a 5-point improvement scale. Physician's Global Assessment (min= -1; max=4) Higher scores mean better outcome | Only 5 subjects were treated and then assessed at 24 weeks in their upper chest area | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
|
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|
| 0 |
| 24 |
| 0 |
| 24 |
| 24 |
| 24 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
|