Calcium Electroporation for the Treatment of Keloids
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01941914|
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : November 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Keloid||Drug: Calcium chloride||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Calcium Electroporation for the Treatment of Keloids|
|Actual Study Start Date :||August 2013|
|Actual Primary Completion Date :||May 1, 2018|
|Actual Study Completion Date :||May 1, 2018|
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
- Response evaluated by Vancouver Scar Scale [ Time Frame: After 6 months ]Vancouver scar scale evaluate the keloids by: pigmentation, pliability, height, and vascularity.
- Adverse events to calcium electroporation. [ Time Frame: After 6 months. ]Describe adverse events using Common Terminology for Adverse Events, version 4.0
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
|Department of Oncology, Copenhagen University hospital, Herlev|
|Herlev, Denmark, 2730|
|Principal Investigator:||Julie Gehl, MD||University of Copenhagen|