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| Descriptive Information Fields | |||||
| Brief Title † | Measurement Skin TemperatureDuring Pulsed Laser Exposure | ||||
| Official Title † | Measurement Skin Temperature During Pulsed Laser Exposure | ||||
| Brief Summary | PURPOSE OF STUDY During laser treatment of port wine stain skin, some light is converted to heat in the top part of the skin as opposed to the deeper port wine stain birthmark. The purpose of this study is to make temperature measurements of the skin during laser treatment to determine how much light is converted to heat in the top part of the skin as opposed to the deeper port wine stain birthmark. The flash lamp pumped pulsed dye laser (FLPDL) and Alexandrite laser are the FDA approved treatments of choice for PWS. The conversion of light to heat in the top part of the skin can lead to permanent scarring or changes in the normal color or pigmentation of the skin. A possible way to avoid these complications of laser therapy is to cool the top part of the skin by the application of a cooling agent. Therefore, skin temperature measurements will also be made while a cooling agent is applied to the skin surface immediately before or during laser treatment. |
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| Detailed Description | Procedure; The study is to compare epidermal temperature measurements in PWS skin during: a) laser treatment at standard treatment energies (5-7 J/cm2); b) CSC plus laser treatment; and c) contact cooling plus laser treatment; d) make temperature measurements on normal human skin with and without cryogen spray cooling. Port Wine Stain sites will be treated with the flash lamp pumped pulsed dye laser (FLPDL) or flash lamp excited long-pulse alexandrite laser (755 mm wavelength) without skin cooling at standard treatment fluences of 5-7 J/ cm2 in 0.5 J/ cm2 increments. Other adjacent sites will be treated with the same amount of light immediately after a short spray of a cooling agent. Before, during, and after the laser pulses, epidermal temperatures will be measured. A compound germanium lens with unit magnification will image the infrared emission from the skin surface onto a 128x128 In Sb fast infrared focal plane array camera sensitive in the 3-5m spectral range with a temperature accuracy of 0.01C. Using white light flash from a camera to the study skin area making measurement as a means to get a quantitative assessment of Port Wine Stain color or redness. Evaluated at each visit by searching for hypertrophic scarring, changes in skin pigmentation, atrophy or induration will be documented clinically, and by photography, and monitored until resolution. |
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| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | Case-Only, Prospective | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Port Wine Stain Birthmark | ||||
| Intervention † | Device: Optical properties mesurement | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Enrolling by invitation | ||||
| Enrollment † | 300 | ||||
| Start Date † | July 2002 | ||||
| Completion Date | July 2012 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 7 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00540917 | ||||
| Organization ID | RR-01192,AR-47551,AR-48458 | ||||
| Secondary IDs †† | Candela Laser Corp, P41-RR01192;NIH-LAMMP | ||||
| Study Sponsor † | University of California, Irvine | ||||
| Collaborators †† | Beckman Laser Institute Medical Clinic | ||||
| Investigators † |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | May 2008 | ||||
| First Received Date † | October 4, 2007 | ||||
| Last Updated Date | May 22, 2008 | ||||
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