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UnknownNCT05771311

KTP Laser vs Pulsed Dye Laser for Port-Wine Stains

Potassium Tetanyl Phosphate Laser vs Pulsed Dye Laser for Treating Port-Wine Stains - A Prospective, Split-Side Study

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Universitätsklinikum Hamburg-Eppendorf · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

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

Detailed 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.

Conditions

Interventions

TypeNameDescription
DEVICEKTPsplit-side, 1 -5 sessions at intervals of 6 - 8 weeks
DEVICEPDLsplit-side, 1 -5 sessions at intervals of 6 - 8 weeks

Timeline

Start date
2023-02-01
Primary completion
2023-05-01
Completion
2023-08-01
First posted
2023-03-16
Last updated
2023-03-16

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT05771311. Inclusion in this directory is not an endorsement.