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Completed

NCT Number: NCT01941914

Calcium Electroporation for the Treatment of Keloids

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

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Key information

Conditions

Keloid Cicatrix Collagen Diseases Connective Tissue Diseases Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Oncology, Copenhagen University hospital, Herlev

Herlev, 2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Calcium chloride

Drug

Other names: Calcium Chloride dihydrate, ATC code A02AC, EV substance codeSUB12664MIG

Primary outcomes

  1. Response evaluated by Vancouver Scar Scale

    Time frame: After 6 months

    Vancouver scar scale evaluate the keloids by: pigmentation, pliability, height, and vascularity.

Secondary outcomes

  1. Adverse events to calcium electroporation.

    Time frame: After 6 months.

    Describe adverse events using Common Terminology for Adverse Events, version 4.0

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2013
Registry last updated
Nov 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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