Dynamic Epidermal Cooling During Pulsed Dye Laser Treatment of Port Wine Stain Birthmark at High Fluences - Full Text View

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

Port Wine Stain

Genetics Home Reference related topics:

Skin Conditions

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Retrospective

Official Title:	Dynamic Epidermal Cooling During Pulsed Dye Laser Treatment of Port Wine Stain

Further study details as provided by University of California, Irvine:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	December 1999
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	1 Month to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

primary care clinic

Criteria

Inclusion Criteria:

Diagnosis of PWS birthmark or age and sex matched control of a subject with a PWS birthmark
Apparent good health as documented by medical history and physical examination
Ability to understand and carry out subject instructions

Exclusion Criteria:

Pregnancy
History of cutaneous photosensitivity
History of photodermatoses, skin cancer or other cancer
Any therapy to the proposed treatment sites within the previous two months
Current participation in any other investigational drug evaluation
Concurrent use of known photosensitizing drugs
Inability to understand and carry out subject instructions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540371

Locations


United States, California
	Beckman Lase Institute Medical Clinic Unversity of California Irvine
	Irvine, California, United States, 92612

Sponsors and Collaborators

University of California, Irvine

Beckman Laser Institute Medical Clinic

Investigators


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:	GM-62177,AR-47551,EB-02495, AR-47551, UTA02-001, P41-RR01192;NIH-LAMMP
First Received:	October 4, 2007
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00540371
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

Port Wine Stain

Study placed in the following topic categories:

Nevi flammei, familial multiple

Port-Wine Stain

Skin Abnormalities

Additional relevant MeSH terms:

Skin Diseases

Congenital Abnormalities

ClinicalTrials.gov processed this record on July 03, 2008

Sponsors and Collaborators:	University of California, Irvine Beckman Laser Institute Medical Clinic
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00540371