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Calcium Electroporation for the Treatment of Keloids

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ClinicalTrials.gov Identifier: NCT01941914
Recruitment Status : Unknown
Verified August 2015 by Julie Gehl, Herlev Hospital.
Recruitment status was:  Recruiting
First Posted : September 13, 2013
Last Update Posted : August 31, 2015
Sponsor:
Information provided by (Responsible Party):
Julie Gehl, Herlev Hospital

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Calcium Electroporation for the Treatment of Keloids
Study Start Date : August 2013
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
U.S. FDA Resources

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



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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

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


Contacts
Contact: Julie Gehl 004538683868 julie.gehl@regionh.dk

Locations
Denmark
Department of Oncology, Copenhagen University hospital, Herlev Recruiting
Herlev, Denmark, 2730
Contact: Julie Gehl    004538683868    julie.gehl@regionh.dk   
Principal Investigator: Julie Gehl         
Sponsors and Collaborators
Herlev Hospital

Responsible Party: Julie Gehl, Medical doctor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01941914     History of Changes
Other Study ID Numbers: AA1310
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: August 31, 2015
Last Verified: August 2015

Keywords provided by Julie Gehl, Herlev Hospital:
Calcium electroporation
calcium
electroporation
electrotransfer
keloid

Additional relevant MeSH terms:
Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs