Calcium Electroporation for the Treatment of Keloids
Verified August 2015 by Herlev Hospital
Information provided by (Responsible Party):
Julie Gehl, Herlev Hospital
First received: September 3, 2013
Last updated: August 28, 2015
Last verified: August 2015
The purpose of this study is to evaluate the effect of calcium electroporation on keloids.
Drug: Calcium chloride
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Calcium Electroporation for the Treatment of Keloids
Primary Outcome Measures:
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2018 (Final data collection date for primary outcome measure)
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
- Calcium Chloride dihydrate
- ATC code A02AC
- EV substance codeSUB12664MIG
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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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
|Department of Oncology, Copenhagen University hospital, Herlev
|Herlev, Denmark, 2730 |
|Contact: Julie Gehl 004538683868 firstname.lastname@example.org |
|Principal Investigator: Julie Gehl |
||Julie Gehl, Medical doctor, Herlev Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 3, 2013
||August 28, 2015
||Denmark: Danish Health and Medicines Authority
Keywords provided by Herlev Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2016
Connective Tissue Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs