Calcium Electroporation for the Treatment of Keloids

Keloid Clinical Trial

Official title:

Calcium Electroporation for the Treatment of Keloids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941914
• Other study ID #: AA1310
• Status: Completed
• Phase: Phase 1
• Start date: August 2013
• Est. completion date: May 1, 2018

Study information

• Verified date: November 2019
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of calcium electroporation on keloids.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Keloid

Intervention

Drug:
• Calcium chloride

Locations

Country	Name	City	State
Denmark	Department of Oncology, Copenhagen University hospital, Herlev	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response evaluated by Vancouver Scar Scale	Vancouver scar scale evaluate the keloids by: pigmentation, pliability, height, and vascularity.	After 6 months
Secondary	Adverse events to calcium electroporation.	Describe adverse events using Common Terminology for Adverse Events, version 4.0	After 6 months.