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| Name | Class |
|---|---|
| Candela Corporation | INDUSTRY |
| Beckman Laser Institute University of California Irvine | OTHER |
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Port wine stain Birthmark is a congenital, progressive vascular malformation of human skin. However, even though the pulsed dye laser is considered as the treatment of choice for Port wine stain Birthmark the degree of fading can remain variable and unpredictable after laser treatment.
The researcher want to use the combination of radiofrequency electrical energy with pulsed dye laser light energy which can improve therapeutic outcome of Port wine stain Birthmark. This investigational device is essentially a combination of two commercially available systems cleared for marketing (K044351 and K052324) provided by Candela Laser Corporation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed Dye Laser | Other | port wine stain treatment using Pulse Dye Laser |
|
| Bipolar Radiofrequency&Pulsed Dye Laser | Experimental | Port wine stain using Combined Bipolar Radiofrequency&Pulsed Dye Laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Dye Laser | Device | port wine stain |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Blanching of Port Wine Stain | Port Wine Stain blood volume fractions in the skin before (fB1), and 8 weeks after (fB2) treatment will be determined using the corresponding visual reflectance spectra measured at the treatment sites. The primary outcome, degree of blanching, B, is computed as B = (fB1-fB2)/fB1. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. Stuart Nelson, M.D., Ph.D. | Beckman Laser Institute, UCI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beckman Laser Institute Medical Clinic | Irvine | California | 92612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Combined Radio Frequency and Pulsed Dye Laser Treatment | This is a within-participant design due to the response of port wine stain to laser therapy varies greatly from patient to patient. Pulsed dye laser only test site and combined radio frequency and pulsed dye laser test site were placed side by side on each subject's port wine stain area. Thus the differences among subjects will be explicitly accounted for and removed from the error component when assessing treatment effects. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Combined Radio Frequency and Pulsed Dye Laser Treatment | There are two test sites on each Port Wine Stain, one test site was treated with Pulsed dye laser only, and another test site was treated with combined radio frequency and pulsed dye laser. Two test sites were placed side by side randomly on each subject's port wine stain area. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment |
| 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 | Percent Change in Blanching of Port Wine Stain | Port Wine Stain blood volume fractions in the skin before (fB1), and 8 weeks after (fB2) treatment will be determined using the corresponding visual reflectance spectra measured at the treatment sites. The primary outcome, degree of blanching, B, is computed as B = (fB1-fB2)/fB1. | Each subject received both treatments on their corresponding test sites. We compared response of test sites to different treatment. | Posted | Mean | Standard Deviation | percentage | 8 weeks | Test site | Test site |
|
8 weeks
No adverse event reported
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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 | Pulsed Dye Laser Only Treatment | Adverse event on the test site treated with Pulsed Dye Laser only. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J Stuart Nelson | University of California, Irvine. Beckamn Laser Institute | 9498247997 | jsnelson@uci.edu |
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| ID | Term |
|---|---|
| D019339 | Port-Wine Stain |
| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D054025 | Lasers, Dye |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Combined Bipolar Radiofrequency&Pulsed Dye Laser | Device | Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment |
|
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Measurement on test sites treated with combined Radio Frequency and Pulsed Dye Laser. |
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Combined Radio Frequency and Pulsed Dye Laser Treatment | Adverse event on test sites treated with combined Radio Frequency and Pulsed Dye Laser. | 0 | 22 | 0 | 22 |
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| D017437 | Skin and Connective Tissue Diseases |