Calcium Electroporation for the Treatment of Keloids

NCT ID: NCT01941914

Last Updated: 2019-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2018-05-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Keloid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Calcium chloride

Intervention Type DRUG

Interventions

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Calcium chloride

Intervention Type DRUG

Other Intervention Names

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Calcium Chloride dihydrate ATC code A02AC EV substance codeSUB12664MIG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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Julie Gehl

Medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie Gehl, MD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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Department of Oncology, Copenhagen University hospital, Herlev

Herlev, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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AA1310

Identifier Type: -

Identifier Source: org_study_id

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