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
1 other identifier
interventional
30
1 country
1
Brief Summary
To compare the efficacy and safety of 532nm KTP laser and 585 nm pulsed dye laser for treating port-wine stains.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2023
CompletedFirst Submitted
Initial submission to the registry
March 5, 2023
CompletedFirst Posted
Study publicly available on registry
March 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedMarch 16, 2023
March 1, 2023
3 months
March 5, 2023
March 5, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
patient satisfaction
at follow-up visit 6 weeks after last treatment session
Study Arms (2)
Potassium Titanyle Phosphate (KTP) Laser
ACTIVE COMPARATORsplit-side, 1 - 5 sessions at intervals of 6 - 8 weeks
Pulsed Dye Laser
ACTIVE COMPARATORsplit-side, 1 - 5 sessions at intervals of 6 - 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laser Department, University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
Related 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.
PMID: 22305042BACKGROUNDUpdyke KM, Khachemoune A. Port-Wine Stains: A Focused Review on Their Management. J Drugs Dermatol. 2017 Nov 1;16(11):1145-1151.
PMID: 29141064BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
L Nguyen
Universitätsklinikum Hamburg-Eppendorf
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2023
First Posted
March 16, 2023
Study Start
February 1, 2023
Primary Completion
May 1, 2023
Study Completion
August 1, 2023
Last Updated
March 16, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share