KTP Laser vs Pulsed Dye Laser for Port-Wine Stains

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

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

Study Overview

• Status: Recruiting
• Conditions: Port-Wine Stain
• Intervention / Treatment: Device: KTP; Device: PDL

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: L Nguyen, MD; Phone Number: +49 (0)40 7410-0; Email: l.nguyen@uke.de

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Recruiting
    • Laser Department, University Medical Center Hamburg-Eppendorf
    • Contact: L Nguyen, MD; Phone Number: 040 7410 0

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: L Nguyen, Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: March 5, 2023
• First Submitted That Met QC Criteria: March 5, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 5, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Congenital Abnormalities; Skin Abnormalities; Hemangioma; Neoplasms, Vascular Tissue; Hemangioma, Capillary; Port-Wine Stain
• Other Study ID Numbers: 03-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No