Electrosclerotherapy for Capillary Malformations

June 26, 2017 updated by: Sophie Horbach

Electrosclerotherapy as a Novel Treatment Option for Capillary Malformations: A Pilot Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Capillary malformations are congenital abnormalities of the capillaries in the skin. These abnormally developed blood vessels cause a red color of the skin (also known as 'port-wine stain'),often in combination with a cobble-stone like aspect of the skin. Currently, the only widely accepted treatment option is laser therapy, in which the abnormal blood vessels are targeted with photocoagulation. However, in approximately 50-60% of patients, treatment outcome of laser therapy is suboptimal. Furthermore, re-darkening of the capillary malformation often occurs after laser therapy. Hence, there is a need for an alternative treatment option - especially for treatment-resistant and recurrent capillary malformations.

Intralesional bleomycin injections (sclerotherapy) are a common treatment option for vascular malformations of blood vessels and lymphatic vessels with a larger diameter (venous and lymphatic malformations). According to the literature, this treatment is effective in approximately 80-90% of patients. Unfortunately, the diameter of capillary blood vessels is too small, and therefore adequate localized injections of bleomycin are not possible in capillary malformations.

'Electroporation' is a physical phenomenon that causes an alteration of the structure of cell membranes through the exposure of cells to a short but intense electric field; this modification of the cell membrane increases its permeability. After electroporation, molecules that normally do not cross the cell membrane, either by diffusion or by active transport, can reach the intracellular environment. Therefore, electroporation is an ideal method for localized drug delivery, in particular for localized bleomycin delivery.

The combination of electroporation and bleomycin is already used in a variety of skin lesions, such as squamous cell carcinoma, with a surprisingly high rate of complete remission. Especially in vascular tumors, such as Kaposi sarcoma, there is an extremely high percentage of complete remission (90%), since the combination of bleomycin and electroporation causes a 'vascular lock' and intravascular thrombosis of tumor vascularization, leading to tumor regression.

This phenomenon (intravascular thrombosis and lesion regression) is exactly the intended effect of capillary malformation treatment.

The investigators therefore hypothesize that intralesional bleomycin injections combined with electroporation (electrosclerotherapy) can be an alternative treatment option for capillary malformations. This proof of principle study aims to explore the feasibility of this potential treatment option in a small patient sample.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105AZ
        • Recruiting
        • Academic Medical Center (AMC)
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sophie E Horbach, MD
        • Principal Investigator:
          • Chantal M van der Horst, MD PhD
        • Sub-Investigator:
          • Albert Wolkerstorfer, MD PhD
        • Sub-Investigator:
          • Martijn de Bruin, MSc PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electrosclerotherapy
One region of interest in the capillary malformation (approximately 1.5x1.5cm)will be treated with electrosclerotherapy
Other: Electrosclerotherapy
Combination of intralesional bleomycin sclerotherapy and electroporation
Other Names:
  • Electrochemotherapy
Active Comparator: Intralesional bleomycin injections
One region of interest in the capillary malformation will be treated with intralesional bleomycin injections without electroporation
Drug: Intralesional bleomycin injection
Local intralesional injections with bleomycin
Other Names:
  • bleomycin sclerotherapy
No Intervention: No treatment
One region of interest in the capillary malformation (approximately 1.5x1.5cm)will not be treated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient and Observer global assessment of capillary malformation (POSAS instrument)
Time Frame: 7 weeks
Change in patient and observer assessment of vascularity, pigmentation, thickness, pliability, relief, surface area and general opinion.
7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 7 weeks
Any adverse event or serious adverse event occurring after intervention
7 weeks
Colorimetry
Time Frame: 7 weeks
Change in color of capillary malformation in relation the contralateral healthy skin
7 weeks
Optical imaging (laser speckle imaging)
Time Frame: 7 weeks
Change in blood perfusion measured with non invasive imaging using light
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sophie Horbach

Collaborators

IGEA

Investigators

  • Principal Investigator: Chantal M van der Horst, MD PhD, Academic Medical Center (AMC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

August 29, 2016

First Posted (Estimate)

August 30, 2016

Study Record Updates

Last Update Posted (Actual)

June 27, 2017

Last Update Submitted That Met QC Criteria

June 26, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 58824

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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