KTP Laser vs Pulsed Dye Laser for Port-Wine Stains

Not Applicable

Recruiting

• Conditions: Port-Wine Stain
• Interventions: Device: PDL; Device: KTP

• Registration Number: NCT05771311
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief 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.

Study Timeline

• Study Start: 2023-02-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-05
• Study First Submitted QC: 2023-03-05
• Last Update Submitted: 2023-03-05
• Study First Posted: 2023-03-16
• Last Update Posted: 2023-03-16
• Primary Completion: 2023-05-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Men and women 18 years and older
• Good general health, no relevant previous diseases
• Presence of one or more port-wine stains
• Cognitive ability and willingness to give consent (Informed Consent)

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Exclusion Criteria

• Age < 18 years
• Pregnant and breastfeeding women
• Significant open wounds or lesions in the region to be treated
• Missing consent and/or data protection declarations

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulsed Dye Laser	PDL	split-side, 1 - 5 sessions at intervals of 6 - 8 weeks
Potassium Titanyle Phosphate (KTP) Laser	KTP	split-side, 1 - 5 sessions at intervals of 6 - 8 weeks

Primary Outcome Measures

Name	Time	Method
area reduction	at follow-up visit 6 weeks after last treatment session	measurement using photo documentation
Erythema	at follow-up visit 6 weeks after last treatment session	assessment scale 1 - 7 (normal skin - dark purple) evaluated by physician and blinded investigator

Secondary Outcome Measures

Name	Time	Method
patient satisfaction	at follow-up visit 6 weeks after last treatment session	assessment scale 1 - 6 (very - not at all) evaluated by subjects

Trial Locations

Locations (1)

Laser Department, University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany