NCT01941914

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

4.8 years

First QC Date

September 3, 2013

Last Update Submit

November 1, 2019

Conditions

Keloid

Keywords

Calcium electroporationcalciumelectroporationelectrotransferkeloid

Outcome Measures

Primary Outcomes (1)

  • Response evaluated by Vancouver Scar Scale

    Vancouver scar scale evaluate the keloids by: pigmentation, pliability, height, and vascularity.

    After 6 months

Secondary Outcomes (1)

  • Adverse events to calcium electroporation.

    After 6 months.

Study Arms (1)

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

Calcium chlorideDRUG
Also known as: Calcium Chloride dihydrate, ATC code A02AC, EV substance codeSUB12664MIG
Calcium electroporation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Copenhagen University hospital, Herlev

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Keloid

Interventions

Calcium Chloride

Condition Hierarchy (Ancestors)

Collagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsChloridesHydrochloric AcidChlorine Compounds

Study Officials

  • Julie Gehl, MD

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

September 3, 2013

First Posted

September 13, 2013

Study Start

August 1, 2013

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

November 5, 2019

Record last verified: 2019-11

Locations

DK(1)