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Calcium Electroporation for the Treatment of Keloids

H

Herlev Hospital

Status and phase

Completed
Phase 1

Conditions

Keloid

Treatments

Drug: Calcium chloride

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of calcium electroporation on keloids.

Full 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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

7 participants in 1 patient group

Calcium electroporation
Experimental group
Description:
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.
Treatment:
Drug: Calcium chloride

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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