Calcium Electroporation for the Treatment of Keloids

November 1, 2019 updated by: Julie Gehl, Herlev Hospital
The purpose of this study is to evaluate the effect of calcium electroporation on keloids.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Department of Oncology, Copenhagen University Hospital, Herlev

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calcium electroporation

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.
Drug: Calcium chloride
Other Names:
  • Calcium Chloride dihydrate
  • ATC code A02AC
  • EV substance codeSUB12664MIG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response evaluated by Vancouver Scar Scale
Time Frame: After 6 months
Vancouver scar scale evaluate the keloids by: pigmentation, pliability, height, and vascularity.
After 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events to calcium electroporation.
Time Frame: After 6 months.
Describe adverse events using Common Terminology for Adverse Events, version 4.0
After 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Investigators

  • Principal Investigator: Julie Gehl, MD, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

September 3, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (Estimate)

September 13, 2013

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 1, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AA1310

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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