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

Completed

• Conditions: Port Wine Stain
• Interventions: Other: Port wine stain Birthmark

• Registration Number: NCT00540371
• Lead Sponsor: University of California, Irvine

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.

Study Timeline

• Study Start: 1999-12
• Study First Submitted: 2007-10-04
• Study First Submitted QC: 2007-10-04
• Study First Posted: 2007-10-08
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Port wine stain Birthmark	Port wine stain Birthmark	Port wine stain Birthmark

Trial Locations

Locations (1)

Beckman Lase Institute Medical Clinic Unversity of California Irvine; 🇺🇸 Irvine, California, United States