Electrosclerotherapy for Capillary Malformations

• Status: Unknown status
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sophie Horbach
• Collaborator: IGEA
• Treatments: Bleomycin

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:

• Pregnant or breastfeeding women

• Women with childbearing potential not using contraception

• Patients with chronic renal dysfunction of GFR <50 ml/minute

• Patients with chronic pulmonary dysfunction, active pulmonary infections or previous bleomycin lung toxicity

• Patients with ataxia teleangiectasia

• Patients with previous allergic reactions to bleomycin

• Patients who already received the maximum dose of bleomycin (400 mg or 400000 IU/m2)

• Patients with implanted electrical devices such as pacemakers or ICD's

• Patients with clinically manifested arrhythmia

• Patients with epilepsy

• Patients who are not able to return to the hospital for follow-up visits

• Patients who are likely not able to understand the terms and risks of the study (e.g. cognitive impairment)