The primary objective of this study is to assess the efficacyand safety of modifications of the laser treatment to increase the clearance of port wine stains.
ID
Source
Brief title
Condition
- Skin vascular abnormalities
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clearance of the port wine stain as assessed by colour measurement through
reflectance spectroscopy by a blinded investigator.
Secondary outcome
Visual assessment of clearance and side-effects by a blinded investigator.
Background summary
Modified treatment of port wine stains with the pulsed dye laser: a randomised
controlled trial
Pulsed dye laser (PDL) is the first choice for the treatment of port wine
stains (PWS). However, the outcome is highly variable and there is a
substantial part of patients resistant for further treatment. Especially the
small capillaries in PWS are resistant to laser treatment. Increasing the
dermal blood volume or a second pass may improve the outcome of laser treatment
of PWS.
Study objective
The primary objective of this study is to assess the efficacy
and safety of modifications of the laser treatment to increase the clearance of
port wine stains.
Study design
Prospective single blinded randomised within-patient controlled study.
Intervention
Two similar parts of the PWS measuring 2x2cm will be randomly allocated to PDL
treatment with or without modification of the technique.
Modification in PWS*s on the extremities involves an increase of dermal blood
volume by inflating a blood pressure cuff (90±10 mm Hg).
Modification in PWS*s in other regions involves a second pass after 6 minutes.
A long pulse PDL (V beam laser) operating at 595 nm will be used with
standardised settings. Three months after two treatments, 8 weeks apart, the
clearance of the PWS will be assessed using both visual assessment and
objective colour measurement.
Study burden and risks
Subjects participating in the study will not experience delay in the treatment
of the PWS as the whole PWS will be treated at each visit. No additional visits
are necessary for the present study. The extra time investment for the patient
will be 15 minutes at each of the three visits not exceeding a total of 60
minutes. Additional procedures as compared to regular therapy are colour
measurements, the application of an inflated blood pressure cuff (extremities)
or a second pass after 6 minutes (not extremities). As a result of the study
temporary stronger purpuric skin reactions may be expected in the region (2x2
cm) treated by modified PDL. All together the burden due to the study is
minimal and the expected risk is very low and confined to a region of 2x2cm.
Except for a stronger purpuric colour, we do not expect a higher frequency of
local side effects as compared to regular laser treatment. Systemic side
effects are not associated with this kind of laser treatment. If the assessed
modifications are effective, a substantial part of our patients may benefit
from higher clearance rates in the treatment of PWS.
Meibergdreef 35
1105 AZ Amsterdam
Nederland
Meibergdreef 35
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- Subjects with at least one PWS treated previously with the PDL 3 times or more
- PWS with two homogenously coloured parts of at least 2x2 cm;
- Subjects following laser treatment at the Netherlands Institute for Pigment Disorders;
- Age at least 18 years.
Exclusion criteria
- Subjects with hypertrophic PWS;
- Subjects with dark purple PWS;
- In case of a scar after the first PDL treatment in one of the study regions, the patient will be withdrawn from the study.
- Subjects who fail to appear at the planned follow-up visits.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL15191.018.06 |