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 : Unknown
Verified August 2015 by Julie Gehl, Herlev Hospital.
Recruitment status was: Recruiting
First Posted : September 13, 2013
Last Update Posted : August 31, 2015
|Condition or disease||Intervention/treatment||Phase|
|Keloid||Drug: Calcium chloride||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Calcium Electroporation for the Treatment of Keloids|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941914
|Contact: Julie Gehlfirstname.lastname@example.org|
|Department of Oncology, Copenhagen University hospital, Herlev||Recruiting|
|Herlev, Denmark, 2730|
|Contact: Julie Gehl 004538683868 email@example.com|
|Principal Investigator: Julie Gehl|