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Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks: Comparison of 577 nm Versus 595 nm Wavelengths

Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks: Comparison of 577 nm Versus 595 nm Wavelengths

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00573729
Enrollment
56
Registered
2007-12-14
Start date
2007-03-31
Completion date
2009-01-31
Last updated
2022-10-20

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

Conditions

Port Wine Stains

Keywords

vascular malformation

Brief summary

Port wine stain are a congenital, progressive vascular malformation of human skin. The pulsed dye laser is approved by the Food and Drug Administration for the treatment of choice. However, the degree of port wine stain blanching seen following pulsed dye laser treatment remains variable and unpredictable. If the ultimate standard required is complete lesion blanching, the average success rate is below 10%, even after undergoing numerous pulsed dye laser treatments. Moreover, less than 50% of patients achieve 50% fading of their Port wine stain in response to pulsed dye laser therapy.

Detailed description

The researchers' specific aim is to determine whether the use of the pulsed dye laser operating at a wavelength of 577 nm will improve therapeutic outcome as compared to a pulsed dye laser operating at 595 nm. The researcher can treat port wine stain treated using a pulsed dye laser operating at a wavelength of 577 nm and the other half at a wavelength of 595 nm. The researcher can determine that the 577 nm pulsed dye laser improved port wine stain blanching responses more than the areas treated with 595 nm. The degree of port wine stain blanching which will determine by visible reflectance spectroscopy skin imaging device measurements. Post-treatment blanching responses can compare with pre-treatment measurements of port wine stain fractional blood volume.

Interventions

OTHERPulsed Dye Laser 577 nm

Comparison of 577 nm Versus 595 nm Wavelengths of Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

OTHERPulsed Dye Laser 595 nm

Comparison of 577 nm Versus 595 nm Wavelengths of Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

Sponsors

Beckman Laser Institute University of California Irvine
CollaboratorOTHER
University of California, Irvine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No

Inclusion criteria

* Port Wine Stain suitable for comparison testing * Age \> 6 months of age; minor will be accompanied in the room by parents or guardians during laser treatment * Apparent good health as documented by medical history * Ability to understand and carry out subject instructions

Exclusion criteria

* History of photodermatoses or skin cancer * Any therapy within the previous two months to the proposed Port Wine Stain treatment sites * Inability to understand and carry out instructions

Design outcomes

Primary

MeasureTime frame
Improvement in blanching for the 577 nm Pulsed Dye Laser therapy in comparison with 595 nm8 weeks

Countries

United States

Outcome results

None listed

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