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Calcium Electroporation for the Treatment of Keloids

This study is currently recruiting participants.
Verified August 2015 by Julie Gehl, Herlev Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01941914
First Posted: September 13, 2013
Last Update Posted: August 31, 2015
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Julie Gehl, Herlev Hospital
  Purpose
The purpose of this study is to evaluate the effect of calcium electroporation on keloids.

Condition Intervention Phase
Keloid Drug: Calcium chloride Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Calcium Electroporation for the Treatment of Keloids

Resource links provided by NLM:


Further study details as provided by Julie Gehl, Herlev Hospital:

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


Estimated Enrollment: 8
Study Start Date: August 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

Responsible Party: Julie Gehl, Medical doctor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01941914     History of Changes
Other Study ID Numbers: AA1310
First Submitted: September 3, 2013
First Posted: September 13, 2013
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