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Calcium Electroporation for the Treatment of Keloids

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Herlev Hospital
Sponsor:
Information provided by (Responsible Party):
Julie Gehl, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01941914
First received: September 3, 2013
Last updated: September 10, 2013
Last verified: September 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Herlev Hospital:

Primary Outcome Measures:
  • Response evaluated by Vancouver Scar Scale [ Time Frame: After 6 months ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Describe adverse events using Common Terminology for Adverse Events, version 4.0


Estimated Enrollment: 8
Study Start Date: August 2013
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Julie Gehl, Medical doctor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01941914     History of Changes
Other Study ID Numbers: AA1310
Study First Received: September 3, 2013
Last Updated: September 10, 2013
Health Authority: Denmark: Danish Health and Medicines Authority

Keywords provided by Herlev Hospital:
Calcium electroporation
calcium
electroporation
electrotransfer
keloid

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

ClinicalTrials.gov processed this record on November 24, 2014