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Measurement Skin Temperature During Pulsed Laser Exposure

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.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00540917
Enrollment
118
Registered
2007-10-08
Start date
2002-07-31
Completion date
2010-03-31
Last updated
2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Port-Wine Stain

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.

Interventions

PROCEDUREcooling spray during laser treatment

skin temperature measurement

Sponsors

Beckman Laser Institute University of California Irvine
CollaboratorOTHER
Candela Corporation
CollaboratorINDUSTRY
University of California, Irvine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
skin temperature during laser treatment90 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026