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