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| Tracking Information | |||||
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| First Received Date ICMJE | October 4, 2007 | ||||
| Last Updated Date | March 13, 2009 | ||||
| Start Date ICMJE | December 1999 | ||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00540371 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Dynamic Epidermal Cooling During Pulsed Dye Laser Treatment of Port Wine Stain Birthmark at High Fluences | ||||
| Official Title ICMJE | Dynamic Epidermal Cooling During Pulsed Dye Laser Treatment of Port Wine Stain | ||||
| Brief Summary | The purpose of the study is to improve the efficacy of pulsed dye laser treatment of port wine stain birthmarks. Involvement in the protocol will involve formal documentation of the level of treatment pain, duration of post-treatment purpura and incidence of side effects. In addition, measurements will be taken of blood substances that promote blood vessel formation/regrowth and non-invasive reflectance measurements and photographs will be taken before and after treatment. The objective of this study is to document the degree of PWS lightening, the incidence of side effects and the presence of angiogenic factors induced during treatment with the pulsed dye laser in association with cooling agent. This information ultimately lead to improved port wine stain treatment. |
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| Detailed Description | The flashlamp-pumped pulsed dye laser (FLPDL) has offered the best results with the lowest incidence of side effects. The yellow light produced by the FLPDL is preferentially absorbed by hemoglobin allowing more selective destruction of the ectatic capillaries in the dermis. FLPDL has become the treatment of choice for PWS birthmarks; however, therapeutic challenges remain. The epidermis is not totally spared due to partial absorption of energy therein by melanin which presents an optical barrier through which the light must pass to reach the underlying blood vessels. Absorption of laser energy by melanin causes localized heating in the epidermis, which may, if not controlled, produce permanent complications such as hypertrophic scarring or dyspigmentation. Clinical studies have demonstrated the efficacy and safety of cryogen spray cooling during pulsed laser treatment of PWS birthmarks. This technology allows the use of higher incident laser light dosages and has been demonstrated to improve treatment results. CSC also decreases treatment pain and the duration of post-laser treatment purpura. Currently, Candela's (Wayland, MA) ScleroPLUS provides CSC in combination with a tunable dye laser offering wavelengths. This laser is FDA approved and is currently being utilized for treatment of PWS birthmarks at the Beckman Laser Institute and many other laser clinics across the country. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case-Only, Retrospective | ||||
| Condition ICMJE | Port Wine Stain | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 136 | ||||
| Completion Date | February 2009 | ||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 1 Month to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00540371 | ||||
| Responsible Party | Kristen Kelly, MD, Beckman Laser Institute | ||||
| Study ID Numbers ICMJE | LAMMP | ||||
| Study Sponsor ICMJE | University of California, Irvine | ||||
| Collaborators ICMJE | Beckman Laser Institute University of California Irvine | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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