Modified treatment of port wine stains with the pulsed dye laser: a randomised controlled trial

Modified treatment of port wine stains with the pulsed dye laser: a randomised controlled trial - Laser in port wine stain

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30414

Enrollment

Registered

2007-01-26

Start date

2007-02-01

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

capillary malformation port wine stain

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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dark purple PWS; - In case of a scar after the first PDL treatment in one of the study regions, the patient will be withdrawn from the study.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 outcomes

Primary

Measure	Time frame
Clearance of the port wine stain as assessed by colour measurement through reflectance spectroscopy by a blinded investigator.	—

Secondary

Measure	Time frame
Visual assessment of clearance and side-effects by a blinded investigator.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)