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Electrosclerotherapy for Capillary Malformations

Primary Purpose

Capillary Malformations, Vascular Malformations

Status
Unknown status
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Electrosclerotherapy
Intralesional bleomycin injection
Sponsored by
Sophie Horbach
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Capillary Malformations focused on measuring Bleomycin, Electroporation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Academic Medical Center (AMC)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Electrosclerotherapy

Intralesional bleomycin injections

No treatment

Arm Description

One region of interest in the capillary malformation (approximately 1.5x1.5cm)will be treated with electrosclerotherapy

One region of interest in the capillary malformation will be treated with intralesional bleomycin injections without electroporation

One region of interest in the capillary malformation (approximately 1.5x1.5cm)will not be treated.

Outcomes

Primary Outcome Measures

Patient and Observer global assessment of capillary malformation (POSAS instrument)
Change in patient and observer assessment of vascularity, pigmentation, thickness, pliability, relief, surface area and general opinion.

Secondary Outcome Measures

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

Full Information

First Posted
August 22, 2016
Last Updated
June 26, 2017
Sponsor
Sophie Horbach
Collaborators
IGEA
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1. Study Identification

Unique Protocol Identification Number
NCT02883023
Brief Title
Electrosclerotherapy for Capillary Malformations
Official Title
Electrosclerotherapy as a Novel Treatment Option for Capillary Malformations: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sophie Horbach
Collaborators
IGEA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Capillary Malformations, Vascular Malformations
Keywords
Bleomycin, Electroporation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electrosclerotherapy
Arm Type
Experimental
Arm Description
One region of interest in the capillary malformation (approximately 1.5x1.5cm)will be treated with electrosclerotherapy
Arm Title
Intralesional bleomycin injections
Arm Type
Active Comparator
Arm Description
One region of interest in the capillary malformation will be treated with intralesional bleomycin injections without electroporation
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
One region of interest in the capillary malformation (approximately 1.5x1.5cm)will not be treated.
Intervention Type
Other
Intervention Name(s)
Electrosclerotherapy
Other Intervention Name(s)
Electrochemotherapy
Intervention Description
Combination of intralesional bleomycin sclerotherapy and electroporation
Intervention Type
Drug
Intervention Name(s)
Intralesional bleomycin injection
Other Intervention Name(s)
bleomycin sclerotherapy
Intervention Description
Local intralesional injections with bleomycin
Primary Outcome Measure Information:
Title
Patient and Observer global assessment of capillary malformation (POSAS instrument)
Description
Change in patient and observer assessment of vascularity, pigmentation, thickness, pliability, relief, surface area and general opinion.
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Description
Any adverse event or serious adverse event occurring after intervention
Time Frame
7 weeks
Title
Colorimetry
Description
Change in color of capillary malformation in relation the contralateral healthy skin
Time Frame
7 weeks
Title
Optical imaging (laser speckle imaging)
Description
Change in blood perfusion measured with non invasive imaging using light
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie E Horbach, MD
Phone
0031-20-5666679
Email
s.e.horbach@amc.uva.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chantal M van der Horst, MD PhD
Organizational Affiliation
Academic Medical Center (AMC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Medical Center (AMC)
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie E Horbach, MD
Phone
0031205666679
Email
s.e.horbach@amc.uva.nl
First Name & Middle Initial & Last Name & Degree
Albert Wolkerstorfer, MD PhD
Email
a.wolkerstorfer@amc.uva.nl
First Name & Middle Initial & Last Name & Degree
Sophie E Horbach, MD
First Name & Middle Initial & Last Name & Degree
Chantal M van der Horst, MD PhD
First Name & Middle Initial & Last Name & Degree
Albert Wolkerstorfer, MD PhD
First Name & Middle Initial & Last Name & Degree
Martijn de Bruin, MSc PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31574025
Citation
Horbach SER, Wolkerstorfer A, Jolink F, Bloemen PR, van der Horst CMAM. Electrosclerotherapy as a Novel Treatment Option for Hypertrophic Capillary Malformations: A Randomized Controlled Pilot Trial. Dermatol Surg. 2020 Apr;46(4):491-498. doi: 10.1097/DSS.0000000000002191.
Results Reference
derived
PubMed Identifier
29138199
Citation
Horbach SER, Wolkerstorfer A, de Bruin DM, Jansen SM, van der Horst CMAM. Electrosclerotherapy for capillary malformations: study protocol for a randomised within-patient controlled pilot trial. BMJ Open. 2017 Nov 14;7(11):e016401. doi: 10.1136/bmjopen-2017-016401. Erratum In: BMJ Open. 2018 Jan 27;8(1):e016401corr1.
Results Reference
derived

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Electrosclerotherapy for Capillary Malformations

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