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Clinical Trial Summary

To compare the efficacy and safety of 532nm KTP laser and 585 nm pulsed dye laser for treating port-wine stains.


Clinical Trial Description

Nevus flammeus is a vascular, primarily capillary malformation visible from birth on. In rare cases, it may also affect venous and/or arterial vascular systems of the skin or other organs [1]. It occurs in 0.3%-0.5% of the population [1], i.e. in about 3-4 out of 1000 newborns, and is thus the most frequent vascular malformation in children. The cause is a permanent dilatation of the capillary vessels, which is caused by a lack of sympathetic nerve fibers or a lower density of the same. First-line therapy of port-wine stains consists of laser treatment with the long-pulsed dye laser [2] with a wavelength of 595nm. Treatment must be performed at least 10 times at intervals of about 8 weeks and leads to lightening and reduction of lesions. In recent years, problems have often arisen in care of port-wine stain patients because dye lasers often failed due to the instability of technology, resulting in treatment delays. Novel long-pulsed KTP lasers may be a sufficient alternative to pulsed dye lasers in treatment of port-wine stains. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05771311
Study type Interventional
Source Universitätsklinikum Hamburg-Eppendorf
Contact L Nguyen, MD
Phone +49 (0)40 7410-0
Email l.nguyen@uke.de
Status Recruiting
Phase N/A
Start date February 1, 2023
Completion date August 1, 2023

See also
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Completed NCT04106258 - A Pilot Study of Hemoporfin PDT in Children(2-7 Years Old) With Port-wine Stain Phase 4
Recruiting NCT05841628 - Tolerability of 532 nm Laser Treatment of Port Wine Stains N/A
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Completed NCT01924273 - Novel Treatment for Port Wine Stain Birthmarks Phase 1
Terminated NCT02214706 - Treatment of Port Wine Stains Using Pulsed Dye Laser, Erbium Yag Laser and Topical Sirolimus N/A
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Completed NCT04999618 - A New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology Phase 4
Completed NCT01774552 - Evaluate the Port-wine Stain Birthmark Treatment Before and After Pulsed Dye Laser Treatment
Completed NCT01775722 - Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment N/A
Not yet recruiting NCT05171894 - A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin + PDT Phase 2
Completed NCT03181984 - Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain Phase 4
Completed NCT03125057 - A Pilot Study of Hemoporfin PDT in Children With Port-wine Stain Phase 4
Completed NCT02051101 - Pathogenic Mechanisms of Port Wine Stain and Repository of Port Wine Stain Biopsy Samples N/A