Electrosclerotherapy for Capillary Malformations

NCT02883023 | Unknown Phase 2 DMC

• 1 other identifier: 58824
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Capillary Malformations; Vascular Malformations

Keywords

Bleomycin; Electroporation

Outcome Measures

Primary Outcomes (1)

• 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.

  7 weeks

Secondary Outcomes (3)

• Adverse events

  7 weeks

• Colorimetry

  7 weeks

• Optical imaging (laser speckle imaging)

  7 weeks

Study Arms (3)

Electrosclerotherapy

EXPERIMENTAL

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

Other: Electrosclerotherapy

Intralesional bleomycin injections

ACTIVE COMPARATOR

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

Drug: Intralesional bleomycin injection

No treatment

NO INTERVENTION

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

Interventions

Electrosclerotherapy OTHER

Combination of intralesional bleomycin sclerotherapy and electroporation

Also known as: Electrochemotherapy

Electrosclerotherapy

Intralesional bleomycin injection DRUG

Local intralesional injections with bleomycin

Also known as: bleomycin sclerotherapy

Intralesional bleomycin injections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sophie Horbach: lead
• IGEA: collaborator

Study Sites (1)

Academic Medical Center (AMC)

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

Related Publications (2)

• 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.

  PMID: 31574025 DERIVED

• 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.

  PMID: 29138199 DERIVED

MeSH Terms

Conditions

Capillary Malformations, Congenital, 1; Vascular Malformations

Interventions

Electrochemotherapy

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Electroporation Therapies; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Chantal M van der Horst, MD PhD

  Academic Medical Center (AMC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie E Horbach, MD

CONTACT

0031-20-5666679; s.e.horbach@amc.uva.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 30, 2016
• Study Start: November 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: March 1, 2018
• Last Updated: June 27, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)