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Electrosclerotherapy for Capillary Malformations

NCT02883023 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-06-27

No results posted yet for this study

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.

Conditions

  • Capillary Malformations
  • Vascular Malformations

Interventions

OTHER

Electrosclerotherapy

Combination of intralesional bleomycin sclerotherapy and electroporation

DRUG

Intralesional bleomycin injection

Local intralesional injections with bleomycin

Sponsors & Collaborators

  • IGEA

    collaborator INDUSTRY

  • Sophie Horbach

    lead OTHER

Principal Investigators

  • Chantal M van der Horst, MD PhD · Academic Medical Center (AMC)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-01-31
Completion
2018-03-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02883023 on ClinicalTrials.gov