Clinical trial NCT00540371: Dynamic Epidermal Cooling During Pulsed Dye Laser Treatment of Port Wine Stain Birthmark at High Fluences
Official title: Dynamic Epidermal Cooling During Pulsed Dye Laser Treatment of Port Wine Stain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Port Wine Stain
Keywords: Port Wine Stain
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2007-10-08
Enrollment: 136
Sex: ALL
Minimum age (years): 1
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

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 port wine stain 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 treatment.

Detailed description: The flashlamp-pumped pulsed dye laser has offered the best results with the lowest incidence of side effects. The yellow light is preferentially absorbed by hemoglobin allowing more selective destruction of the ectatic capillaries in the dermis.

The flashlamp-pumped pulsed dye laser has become the treatment of choice for port wine stain 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 port wine stain birthmarks. This technology allows the use of higher incident laser light dosages and has been demonstrated to improve treatment results. cryogen spray cooling also decreases treatment pain and the duration of post-laser treatment purpura.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Lase Institute Medical Clinic Unversity of California Irvine
state: California
Study officials:
affiliation: Beckman Laser Institue University of California Irvine
name: Kristen Kelly, M.D
role: PRINCIPAL_INVESTIGATOR
References: