Back to resultsCalcium Electroporation for the Treatment of Keloids
Primary Purpose
Keloid
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Calcium chloride
Sponsored by
About this trial
This is an interventional treatment trial for Keloid focused on measuring Calcium electroporation, calcium, electroporation, electrotransfer, keloid
Eligibility 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.
Sites / Locations
- Department of Oncology, Copenhagen University hospital, Herlev
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Calcium electroporation
Arm Description
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.
Outcomes
Primary Outcome Measures
Response evaluated by Vancouver Scar Scale
Vancouver scar scale evaluate the keloids by: pigmentation, pliability, height, and vascularity.
Secondary Outcome Measures
Adverse events to calcium electroporation.
Describe adverse events using Common Terminology for Adverse Events, version 4.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01941914
Brief Title
Calcium Electroporation for the Treatment of Keloids
Official Title
Calcium Electroporation for the Treatment of Keloids
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of calcium electroporation on keloids.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid
Keywords
Calcium electroporation, calcium, electroporation, electrotransfer, keloid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calcium electroporation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Calcium chloride
Other Intervention Name(s)
Calcium Chloride dihydrate, ATC code A02AC, EV substance codeSUB12664MIG
Primary Outcome Measure Information:
Title
Response evaluated by Vancouver Scar Scale
Description
Vancouver scar scale evaluate the keloids by: pigmentation, pliability, height, and vascularity.
Time Frame
After 6 months
Secondary Outcome Measure Information:
Title
Adverse events to calcium electroporation.
Description
Describe adverse events using Common Terminology for Adverse Events, version 4.0
Time Frame
After 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Gehl, MD
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, Copenhagen University hospital, Herlev
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Calcium Electroporation for the Treatment of Keloids
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