KTP Laser vs Pulsed Dye Laser for Port-Wine Stains

Port-Wine Stain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05771311
• Other study ID #: 03-21
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: August 1, 2023

Study information

• Verified date: March 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: L Nguyen, MD
• Phone: +49 (0)40 7410-0
• Email: l.nguyen[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemangioma, Capillary
• Port-Wine Stain

Intervention

Device:
• KTP
split-side, 1 -5 sessions at intervals of 6 - 8 weeks
• PDL
split-side, 1 -5 sessions at intervals of 6 - 8 weeks

Locations

Country	Name	City	State
Germany	Laser Department, University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

Updyke KM, Khachemoune A. Port-Wine Stains: A Focused Review on Their Management. J Drugs Dermatol. 2017 Nov 1;16(11):1145-1151. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	area reduction	measurement using photo documentation	at follow-up visit 6 weeks after last treatment session
Secondary	patient satisfaction	assessment scale 1 - 6 (very - not at all) evaluated by subjects	at follow-up visit 6 weeks after last treatment session