Neoplasms

All Conditions

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Hemangioma, Capillary

Port-Wine Stain

Hemangioma

Congenital Abnormalities

Skin Abnormalities

Skin Diseases

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

port wine stain treatment using Pulse Dye Laser

Port wine stain using Combined Bipolar Radiofrequency\&Pulsed Dye Laser

Pulsed Dye Laser

Combined Bipolar Radiofrequency\&Pulsed Dye Laser Treatment

Combined Bipolar Radiofrequency&Pulsed Dye Laser

J. Stuart Nelson, M.D., Ph.D.

Port wine stain Birthmark is a congenital, progressive vascular malformation of human skin. However, even though the pulsed dye laser is considered as the treatment of choice for Port wine stain Birthmark the degree of fading can remain variable and unpredictable after laser treatment.

The researcher want to use the combination of radiofrequency electrical energy with pulsed dye laser light energy which can improve therapeutic outcome of Port wine stain Birthmark. This investigational device is essentially a combination of two commercially available systems cleared for marketing (K044351 and K052324) provided by Candela Laser Corporation.

Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment

Combined Bipolar Radiofrequency and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

Port Wine Stain blood volume fractions in the skin before (fB1), and 8 weeks after (fB2) treatment will be determined using the corresponding visual reflectance spectra measured at the treatment sites. The primary outcome, degree of blanching, B, is computed as B = (fB1-fB2)/fB1.

Candela Corporation

Beckman Laser Institute University of California Irvine

University of California, Irvine

J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering

Adverse event on the test site treated with Pulsed Dye Laser only.

Pulsed Dye Laser Only Treatment

Adverse event on test sites treated with combined Radio Frequency and Pulsed Dye Laser.

Combined Radio Frequency and Pulsed Dye Laser Treatment

There are two test sites on each Port Wine Stain, one test site was treated with Pulsed dye laser only, and another test site was treated with combined radio frequency and pulsed dye laser. Two test sites were placed side by side randomly on each subject's port wine stain area.

Age, Categorical

Sex: Female, Male

J Stuart Nelson

Measurement on the test site treated with Pulsed Dye Laser only.

Measurement on test sites treated with combined Radio Frequency and Pulsed Dye Laser.

Each subject received both treatments on their corresponding test sites. We compared response of test sites to different treatment.

Percent Change in Blanching of Port Wine Stain

This is a within-participant design due to the response of port wine stain to laser therapy varies greatly from patient to patient. Pulsed dye laser only test site and combined radio frequency and pulsed dye laser test site were placed side by side on each subject's port wine stain area. Thus the differences among subjects will be explicitly accounted for and removed from the error component when assessing treatment effects.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment	NCT01775722	Port-Wine Stain	Pulsed Dye Lase... Combined Bipola...	12 Years -	University of California, Irvine
Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment	NCT01775722	Port-Wine Stain	Pulsed Dye Lase... Combined Bipola...	12 Years -	University of California, Irvine

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