Calcium Electroporation for the Treatment of Keloids
The purpose of this study is to evaluate the effect of calcium electroporation on keloids.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Calcium Electroporation for the Treatment of Keloids|
- Response evaluated by Vancouver Scar Scale [ Time Frame: After 6 months ] [ Designated as safety issue: No ]Vancouver scar scale evaluate the keloids by: pigmentation, pliability, height, and vascularity.
- Adverse events to calcium electroporation. [ Time Frame: After 6 months. ] [ Designated as safety issue: No ]Describe adverse events using Common Terminology for Adverse Events, version 4.0
|Study Start Date:||August 2013|
|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
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.
|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|