Determine the feasibility and explore the efficacy and safety of electrosclerotherapy as a novel treatment option for capillary malformations.
ID
Source
Brief title
Condition
- Blood and lymphatic system disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study parameters are (change in) global assessment of color, thickness,
nodularity, pliability, surface area and overall improvement by both the
blinded patient and a blinded observer using a global assessment score and the
POSAS instrument.
Secondary outcome
Number and type(s) of adverse events.
(Change in) objective color measurement using colorimetry.
(Change in) perfusion measured using optical imaging.
Background summary
Capillary malformations (*port-wine stains*) are congenital abnormalities of
the capillary vessels of the skin, causing a red or purple color. Laser therapy
is currently the only widely accepted treatment option, but treatment response
is suboptimal in approximately half of patients. In capillary malformations
with hypertrophy, increased thickness of the (sub)cutaneous tissue, treatment
response is even poorer. Hence, there is a need for an alternative treatment
option for capillary malformations.
Intralesional bleomycin injections (sclerotherapy) are commonly used to treat
vascular malformations of larger sized vessels, but cannot be used in capillary
malformations because the vessel diameter is too small for accurate
intravascular injections. Therefore, bleomycin cannot reach the endothelial
cells where it has its therapeutic sclerosing effect.
*Electroporation' is a physical phenomenon that increases the permeability of
cell membranes through the exposure of cells to an electric field, which allows
molecules and drugs to easily cross cell membranes. The combination of
electroporation and the regular intralesional bleomycin injections
(*electrosclerotherapy*) could facilitate localized bleomycin delivery to
endothelial cells and subsequent vascular depletion, ultimately leading to
regression of the capillary malformation. Electrosclerotherapy has been safely
used in many skin lesions with high effectiveness rates, especially in vascular
tumors. We hypothesize that electrosclerotherapy can also be a feasible and
safe alternative treatment option for capillary malformations.
Study objective
Determine the feasibility and explore the efficacy and safety of
electrosclerotherapy as a novel treatment option for capillary malformations.
Study design
Prospective, randomized, within-patient controlled pilot study.
Intervention
All participants undergo one intervention session in which 3 homogeneous
1.5x1.5 cm parts of the capillary malformation are randomly allocated to [1]
electrosclerotherapy, [2] bleomycin injection without electroporation or [3] no
treatment.
Study burden and risks
The patient visits the hospital 3 times: [1] treatment visit (t=0), [2] wound
check visit (t=1 week) and [3] outcome measurement visit (t=7 weeks). The
treatment procedure consists of local anesthesia, injections with bleomycin
and/or non-invasive electroporation. Potential risks of treatment are local
bleeding, wound healing disorders and allergic reactions to bleomycin.
Potential benefits are reduction of red color, hypertrophy/nodularity and
bleeding symptoms. Outcome measurement procedures are non-invasive, using
patient and observer scores, colorimetry and optical imaging.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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 dysfuction, 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)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-003238-26-NL |
| CCMO | NL58824.018.16 |