Capillary malformations port-wine stains
Conditions
Interventions
All participants undergo one intervention session in which 3 homogeneous
1.5x1.5 cm parts of the capillary malformation are randomly allocated to [1]
electrosclerotherapy, [2] bleomycin injection wi
bleomycin
capillary malformations
port-wine stains
vascular malformations
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Patients with *1 completely or partially hypertrophic capillary malformation not exclusively located in the skin of the face, the skin overlying joints or in mucosal tissue - Age * 18 years - Fitzpatrick skin type 1-3 without evident sun tan
Exclusion criteria
Exclusion criteria: - Pregnant or breastfeeding women - Women with childbearing potential not using contraception - Patients with chronic renal dysfunction of GFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study parameters are (change in) global assessment of color, thickness, nodularity, pliability, surface area and overall improvement by both the blinded patient and a blinded observer using a global assessment score and the POSAS instrument. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and type(s) of adverse events. (Change in) objective color measurement using colorimetry. (Change in) perfusion measured using optical imaging. | — |
Countries
The Netherlands
Outcome results
None listed