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KTP Laser vs Pulsed Dye Laser for Port-Wine Stains

Primary Purpose

Port-Wine Stain

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

KTP

PDL

About this trial

This is an interventional treatment trial for Port-Wine Stain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Laser Department, University Medical Center Hamburg-EppendorfRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Potassium Titanyle Phosphate (KTP) Laser

Pulsed Dye Laser

Arm Description

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

Outcomes

Primary Outcome Measures

Erythema

assessment scale 1 - 7 (normal skin - dark purple) evaluated by physician and blinded investigator

area reduction

measurement using photo documentation

Secondary Outcome Measures

patient satisfaction

assessment scale 1 - 6 (very - not at all) evaluated by subjects

Full Information

NCT ID

NCT05771311

First Posted

March 5, 2023

Last Updated

March 5, 2023

Sponsor

Universitätsklinikum Hamburg-Eppendorf

1. Study Identification

Unique Protocol Identification Number

NCT05771311

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2023 (Actual)

Primary Completion Date

May 1, 2023 (Anticipated)

Study Completion Date

August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Port-Wine Stain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Potassium Titanyle Phosphate (KTP) Laser

Arm Type

Active Comparator

Arm Description

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

Arm Title

Pulsed Dye Laser

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

KTP

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

PDL

Intervention Description

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

Primary Outcome Measure Information:

Title

Erythema

Description

assessment scale 1 - 7 (normal skin - dark purple) evaluated by physician and blinded investigator

Time Frame

at follow-up visit 6 weeks after last treatment session

Title

area reduction

Description

measurement using photo documentation

Time Frame

at follow-up visit 6 weeks after last treatment session

Secondary Outcome Measure Information:

Title

patient satisfaction

Description

assessment scale 1 - 6 (very - not at all) evaluated by subjects

Time Frame

at follow-up visit 6 weeks after last treatment session

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

L Nguyen, MD

Phone

+49 (0)40 7410-0

l.nguyen@uke.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

L Nguyen

Organizational Affiliation

Universitätsklinikum Hamburg-Eppendorf

Official's Role

Principal Investigator

Facility Information:

Facility Name

Laser Department, University Medical Center Hamburg-Eppendorf

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

L Nguyen, MD

Phone

040 7410 0

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22305042

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.

Results Reference

background

PubMed Identifier

29141064

Citation

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

Results Reference

background

Learn more about this trial

KTP Laser vs Pulsed Dye Laser for Port-Wine Stains

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