Phase II Clinical Trial is to Compare Epidermal Temperature Measurements During 1.Laser Treatment at Standard Treatment Energies 2.Cryogen Spray Cooling (CSC) Plus Laser Treatment. 3.Contact Cooling Plus Laser Treatment.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- skin temperature during laser treatment
Study Overview
Brief Summary
Lasers are the treatment modality of choice for Port Wine Stain birthmarks.The epidermis is not totally spared due to partial absorption of energy therein by melanin that 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.
Detailed Description
The researchers want to establish a correlation between non-invasive skin temperature measurements and the minimum laser energy during skin laser treatment using cryogen spray cooling.
This study would eliminate the need for test pulses to estimate the safe and acceptable radiant exposure prior to laser treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •7 years of age and older with diagnosis of port wine stain birthmark
- •18 years of age and older with no port wine stain
- •non-pregnant women
- •apparent good health
Exclusion Criteria
- •age less than 7 years old
- •pregnant women
- •history of photodermatoses or skin cancer
- •current use of photosensitizing drugs
Arms & Interventions
cooling spray
cooling spray during laser treatment
Intervention: cooling spray during laser treatment (Procedure)
Outcomes
Primary Outcomes
skin temperature during laser treatment
Time Frame: 90 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Beckman Laser Institute and Medical Center
J S Nelson, M.D., Ph.D.,Professor of Surgery and Biomedical Engineering
University of California, Irvine