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Calcium Electroporation for the Treatment of Keloids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01941914
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Julie Gehl, Herlev Hospital

Study Description
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Brief Summary:
The purpose of this study is to evaluate the effect of calcium electroporation on keloids.

Condition or disease Intervention/treatment Phase
Keloid Drug: Calcium chloride Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Calcium Electroporation for the Treatment of Keloids
Actual Study Start Date : August 2013
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Adverse events to calcium electroporation. [ Time Frame: After 6 months. ]
    Describe adverse events using Common Terminology for Adverse Events, version 4.0


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941914


Locations
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Denmark
Department of Oncology, Copenhagen University hospital, Herlev
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Investigators
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Principal Investigator: Julie Gehl, MD University of Copenhagen
More Information
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Responsible Party: Julie Gehl, Medical doctor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01941914    
Other Study ID Numbers: AA1310
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Keywords provided by Julie Gehl, Herlev Hospital:
Calcium electroporation
calcium
electroporation
electrotransfer
keloid
Additional relevant MeSH terms:
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Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes
 Calcium, Dietary
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents