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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Potassium Titanyle Phosphate (KTP) Laser | Active Comparator | split-side, 1 - 5 sessions at intervals of 6 - 8 weeks |
|
| Pulsed Dye Laser | Active Comparator | split-side, 1 - 5 sessions at intervals of 6 - 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KTP | Device | split-side, 1 -5 sessions at intervals of 6 - 8 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| L Nguyen, MD | Contact | +49 (0)40 7410-0 | l.nguyen@uke.de |
| Name | Affiliation | Role |
|---|---|---|
| L Nguyen | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser Department, University Medical Center Hamburg-Eppendorf | Recruiting | Hamburg | 20246 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22305042 | Background | Chen JK, Ghasri P, Aguilar G, van Drooge AM, Wolkerstorfer A, Kelly KM, Heger M. An overview of clinical and experimental treatment modalities for port wine stains. J Am Acad Dermatol. 2012 Aug;67(2):289-304. doi: 10.1016/j.jaad.2011.11.938. Epub 2012 Feb 3. | |
| 29141064 | Background | Updyke KM, Khachemoune A. Port-Wine Stains: A Focused Review on Their Management. J Drugs Dermatol. 2017 Nov 1;16(11):1145-1151. |
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| ID | Term |
|---|---|
| D019339 | Port-Wine Stain |
| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
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| PDL | Device | split-side, 1 -5 sessions at intervals of 6 - 8 weeks |
|
| D017437 | Skin and Connective Tissue Diseases |