Electrosclerotherapy as a novel treatment option for capillary malformations: a pilot study
- Conditions
- Capillary malformationsport-wine stains10005330
- Registration Number
- NL-OMON45598
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
- 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
- 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The study parameters are (change in) global assessment of color, thickness,<br /><br>nodularity, pliability, surface area and overall improvement by both the<br /><br>blinded patient and a blinded observer using a global assessment score and the<br /><br>POSAS instrument. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Number and type(s) of adverse events.<br /><br>(Change in) objective color measurement using colorimetry.<br /><br>(Change in) perfusion measured using optical imaging.</p><br>
Related Research Topics
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