Trial record 6 of 1223 for:
Open Studies | dietary calcium
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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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 July 27, 2016
Connective Tissue Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs