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| Sponsors and Collaborators: |
University of California, Irvine Beckman Laser Institute University of California Irvine |
|---|---|
| Information provided by: | University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00540371 |
Purpose
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.
| Condition |
|---|
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Port Wine Stain |
| Study Type: | Observational |
| Study Design: | Case-Only, Retrospective |
| Official Title: | Dynamic Epidermal Cooling During Pulsed Dye Laser Treatment of Port Wine Stain |
| Enrollment: | 136 |
| Study Start Date: | December 1999 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 1 Month to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
primary care clinic
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Beckman Lase Institute Medical Clinic Unversity of California Irvine | |
| Irvine, California, United States, 92612 | |
| Principal Investigator: | Kristen Kelly, M.D | Beckman Laser Institue University of California Irvine |
More Information
| Responsible Party: | Beckman Laser Institute ( Kristen Kelly, MD ) |
| Study ID Numbers: | LAMMP |
| Study First Received: | October 4, 2007 |
| Last Updated: | March 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00540371 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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Port Wine Stain |
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Skin Diseases Nevi Flammei, Familial Multiple Port-Wine Stain Skin Abnormalities Congenital Abnormalities |
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Skin Diseases Port-Wine Stain Skin Abnormalities Congenital Abnormalities |
