KTP Laser vs Pulsed Dye Laser for Port-Wine Stains

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

Detailed Description
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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.

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

Conditions
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Port-Wine Stain

Intervention / Treatment
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* Device: KTP
* Device: PDL


Participation Criteria
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Eligibility Criteria
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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) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Potassium Titanyle Phosphate (KTP) Laser<br>split-side, 1 - 5 sessions at intervals of 6 - 8 weeks | Device: KTP<br>* split-side, 1 -5 sessions at intervals of 6 - 8 weeks<br>|
| Active Comparator: Pulsed Dye Laser<br>split-side, 1 - 5 sessions at intervals of 6 - 8 weeks | Device: PDL<br>* split-side, 1 -5 sessions at intervals of 6 - 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction | assessment scale 1 - 6 (very - not at all) evaluated by subjects | at follow-up visit 6 weeks after last treatment session |