KTP Laser vs Pulsed Dye Laser for Port-Wine Stains

NCT ID: NCT05771311

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-08-01

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.

Conditions

Port-Wine Stain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Potassium Titanyle Phosphate (KTP) Laser

split-side, 1 - 5 sessions at intervals of 6 - 8 weeks

Group Type: ACTIVE_COMPARATOR

KTP

Intervention Type: DEVICE

split-side, 1 -5 sessions at intervals of 6 - 8 weeks

Pulsed Dye Laser

split-side, 1 - 5 sessions at intervals of 6 - 8 weeks

Group Type: ACTIVE_COMPARATOR

PDL

Intervention Type: DEVICE

split-side, 1 -5 sessions at intervals of 6 - 8 weeks

Interventions

KTP

split-side, 1 -5 sessions at intervals of 6 - 8 weeks

Intervention Type: DEVICE

PDL

split-side, 1 -5 sessions at intervals of 6 - 8 weeks

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

L Nguyen

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

Laser Department, University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

L Nguyen, MD

Role: CONTACT

l.nguyen@uke.de

+49 (0)40 7410-0

Facility Contacts

L Nguyen, MD

Role: primary

040 7410 0

References

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.

Reference Type: BACKGROUND

PMID: 22305042 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 29141064 (View on PubMed)

Other Identifiers

03-21

Identifier Type: -

Identifier Source: org_study_id