drugset / Trial / NCT02883023

Electrosclerotherapy for Capillary Malformations

NCT02883023

Phase 2 Unknown 20 enrolled Sophie Horbach IGEA · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

Capillary malformations (port-wine stains) consist of abnormally developed capillary blood vessels in the skin. To date, laser therapy is the only widely accepted treatment modality for capillary malformations, but this therapy has a suboptimal effect in approximately 50-60% of patients. Intralesional bleomycin injections (sclerotherapy) are a common effective treatment option for vascular malformations with blood vessels with larger diameters. However, bleomycin cannot be injected adequately in the small sized vessels of capillary malformations. The use of an electric field over the tissue (electroporation) may solve this problem: it increases cell membrane permeability and therefore promotes localized delivery of drugs, within (endothelial) cells. Electroporation in combination with bleomycin sclerotherapy ('electrosclerotherapy') may therefore offer new therapeutic options for capillary malformations. This proof of principle study aims to explore the effectiveness, safety and feasibility of this potential treatment option in a within-patient-controlled pilot study.

Timeline

Start
2016-11
Primary completion
2018-01
Completion
2018-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bleomycin Unknown Other