Keloid
Conditions
Keywords
Calcium electroporation, calcium, electroporation, electrotransfer, keloid
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.
Interventions
DRUGCalcium chloride
Sponsors
Herlev Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response evaluated by Vancouver Scar Scale | After 6 months | Vancouver scar scale evaluate the keloids by: pigmentation, pliability, height, and vascularity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events to calcium electroporation. | After 6 months. | Describe adverse events using Common Terminology for Adverse Events, version 4.0 |
Countries
Denmark
Outcome results
None listed