Calcium Electroporation for the Treatment of Keloids
- Registration Number
- NCT01941914
- Lead Sponsor
- Herlev Hospital
- Brief Summary
The purpose of this study is to evaluate the effect of calcium electroporation on keloids.
- Detailed Description
The keloids wil be treated with intratumoral injection of calcium followed by electroporation. It is a once only treatment and the patients will be followed up for 24 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
- At least 1 keloid available to electroporation.
- Patient should have been offered standard treatment.
- At least 8 weeks since other keloid treatment.
- Performance status <2 (ECOG).
- Platelet count >50 mia/l
- International Normalized Ratio (INR) <1,2.
- Age >18.
- Patient should be able to understand participants information.
- Signed, informed consent.
Exclusion Criteria
- Clinically significant coagulopathy.
- Pregnancy or lactation.
- Participation in other clinical trial involving experimental drugs or participation in a clinical trial within 4 weeks before study treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Calcium electroporation Calcium chloride The keloid will be treated with intratumoral injection of calcium chloride followed by electrotransfer. It is a once only treatment. Calcium chlorid concentration is 9 mg/ml Total dose is 0,5ml/cm3 tumor volume.
- Primary Outcome Measures
Name Time Method Response evaluated by Vancouver Scar Scale After 6 months Vancouver scar scale evaluate the keloids by: pigmentation, pliability, height, and vascularity.
- Secondary Outcome Measures
Name Time Method Adverse events to calcium electroporation. After 6 months. Describe adverse events using Common Terminology for Adverse Events, version 4.0
Trial Locations
- Locations (1)
Department of Oncology, Copenhagen University hospital, Herlev
🇩🇰Herlev, Denmark