KTP Laser vs Pulsed Dye Laser for Port-Wine Stains

Sponsor
Universitätsklinikum Hamburg-Eppendorf (Other)
Overall Status
Recruiting
CT.gov ID
NCT05771311
Collaborator
(none)
30
1
2
5.9
5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: KTP
  • Device: PDL
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Potassium Tetanyl Phosphate Laser vs Pulsed Dye Laser for Treating Port-Wine Stains - A Prospective, Split-Side Study
Actual Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Erythema [at follow-up visit 6 weeks after last treatment session]

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

  2. area reduction [at follow-up visit 6 weeks after last treatment session]

    measurement using photo documentation

Secondary Outcome Measures

  1. patient satisfaction [at follow-up visit 6 weeks after last treatment session]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Laser Department, University Medical Center Hamburg-Eppendorf Hamburg Germany 20246

Sponsors and Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: L Nguyen, Universitätsklinikum Hamburg-Eppendorf

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT05771311
Other Study ID Numbers:
  • 03-21
First Posted:
Mar 16, 2023
Last Update Posted:
Mar 16, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2023