Port-Wine Stain
Conditions
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.
Interventions
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| area reduction | at follow-up visit 6 weeks after last treatment session | measurement using photo documentation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patient satisfaction | at follow-up visit 6 weeks after last treatment session | assessment scale 1 - 6 (very - not at all) evaluated by subjects |
Countries
Germany
Contacts
Primary ContactL Nguyen, MD
Outcome results
None listed