Clinical trial NCT05771311: KTP Laser vs Pulsed Dye Laser for Port-Wine Stains
Official title: Potassium Tetanyl Phosphate Laser vs Pulsed Dye Laser for Treating Port-Wine Stains - A Prospective, Split-Side Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Port-Wine Stain
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Erythema
timeFrame: at follow-up visit 6 weeks after last treatment session
measure: area reduction
timeFrame: at follow-up visit 6 weeks after last treatment session
Secondary outcomes:
measure: patient satisfaction
timeFrame: at follow-up visit 6 weeks after last treatment session
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Laser Department, University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: L Nguyen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Updyke KM, Khachemoune A. Port-Wine Stains: A Focused Review on Their Management. J Drugs Dermatol. 2017 Nov 1;16(11):1145-1151.