Electrosclerotherapy for capillary malformations

Authors
Category Primary study
Registry of TrialsNetherlands Trial Register
Year 2016
INTERVENTION: 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 without electroporation or [3] no treatment. CONDITION: Vascular malformations, Capillary malformations ; ; PRIMARY OUTCOME: ‐ (Change in) global assessment of color, thickness, nodularity, pliability, surface area and overall improvement by both the patient and a blinded observer using a global assessment score and the POSAS instrument. ; ; ‐ In terms of safety, we will investigate the number and type(s) of adverse events. SECONDARY OUTCOME: ‐ (Change in) color measured using colorimetry ; ; ‐ (Change in) perfusion of the capillary malformations, measured using optical imaging techniques. ; INCLUSION CRITERIA: ‐ Patients with ¡Ý1 completely or partially hypertrophic capillary malformation not exclusively located in the skin of the face, the skin overlying joints or in mucosal tissue ‐ Age ¡Ý 18 years ‐ Fitzpatrick skin type 1‐3 without evident sun tan
Epistemonikos ID: 9dfd8d29d8e8e6ac87fa22cdaa0ab732f86b77a5
First added on: Aug 24, 2024