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Trial Title:
KTP Laser vs Pulsed Dye Laser for Port-Wine Stains
NCT ID:
NCT05771311
Condition:
Port-Wine Stain
Conditions: Official terms:
Hemangioma, Capillary
Port-Wine Stain
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
KTP
Description:
split-side, 1 -5 sessions at intervals of 6 - 8 weeks
Arm group label:
Potassium Titanyle Phosphate (KTP) Laser
Intervention type:
Device
Intervention name:
PDL
Description:
split-side, 1 -5 sessions at intervals of 6 - 8 weeks
Arm group label:
Pulsed Dye Laser
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Laser Department, University Medical Center Hamburg-Eppendorf
Address:
City:
Hamburg
Zip:
20246
Country:
Germany
Status:
Recruiting
Contact:
Last name:
L Nguyen, MD
Phone:
040 7410 0
Start date:
February 1, 2023
Completion date:
August 1, 2023
Lead sponsor:
Agency:
Universitätsklinikum Hamburg-Eppendorf
Agency class:
Other
Source:
Universitätsklinikum Hamburg-Eppendorf
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05771311
