KTP Laser vs Pulsed Dye Laser for Port-Wine Stains
Study Details
Study Description
Brief Summary
To compare the efficacy and safety of 532nm KTP laser and 585 nm pulsed dye laser for treating port-wine stains.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Potassium Titanyle Phosphate (KTP) Laser split-side, 1 - 5 sessions at intervals of 6 - 8 weeks |
Device: KTP
split-side, 1 -5 sessions at intervals of 6 - 8 weeks
|
Active Comparator: Pulsed Dye Laser split-side, 1 - 5 sessions at intervals of 6 - 8 weeks |
Device: PDL
split-side, 1 -5 sessions at intervals of 6 - 8 weeks
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- patient satisfaction [at follow-up visit 6 weeks after last treatment session]
assessment scale 1 - 6 (very - not at all) evaluated by subjects
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Laser Department, University Medical Center Hamburg-Eppendorf | Hamburg | Germany | 20246 |
Sponsors and Collaborators
- Universitätsklinikum Hamburg-Eppendorf
Investigators
- Principal Investigator: L Nguyen, Universitätsklinikum Hamburg-Eppendorf
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Updyke KM, Khachemoune A. Port-Wine Stains: A Focused Review on Their Management. J Drugs Dermatol. 2017 Nov 1;16(11):1145-1151.
- 03-21