Calcium Electroporation for the Treatment of Keloids | NCT01941914

Studies
Calcium Electroporation for the Treatment of Keloids

NCT01941914

Sponsor

Herlev Hospital

Status

Completed

Last Update Posted

Nov 5, 2019Actual

Enrollment

7Actual

Phase

Phase 1

Conditions

Keloid

Interventions

Calcium chloride

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013Actual

Primary Completion Date

May 1, 2018Actual

Completion Date

May 1, 2018Actual

First Submitted Date

Sep 3, 2013

First Submission Date that Met QC Criteria

Sep 10, 2013

First Posted Date

Sep 13, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2019

Last Update Posted Date

Nov 5, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Calcium electroporation	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Calcium chloride	Drug		Calcium electroporation	Calcium Chloride dihydrate ATC code A02AC EV substance codeSUB12664MIG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response evaluated by Vancouver Scar Scale	Vancouver scar scale evaluate the keloids by: pigmentation, pliability, height, and vascularity.	After 6 months

Secondary Outcomes

Measure	Description	Time Frame
Adverse events to calcium electroporation.	Describe adverse events using Common Terminology for Adverse Events, version 4.0	After 6 months.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julie Gehl, MD	University of Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Oncology, Copenhagen University hospital, Herlev		Herlev		2730	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D007627	Keloid

Ancestor Terms

ID	Term
D003095	Collagen Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D002921	Cicatrix

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002122	Calcium Chloride

Ancestor Terms

ID	Term
D017610	Calcium Compounds
D007287	Inorganic Chemicals
D002712	Chlorides
D006851	Hydrochloric Acid

Browse Leaves

Not provided

Browse Branches

Not provided