KeloidPhase 1NCT01941914
Calcium Electroporation for the Treatment of Keloids
A Phase 1 study testing Calcium chloride in people with Keloid, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate the effect of calcium electroporation on keloids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keloid
- What is being tested?
- Calcium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2013to 1 May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- Age >18.
- Patient should be able to understand participants information.
- Signed, informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Oncology, Copenhagen University hospital, Herlev
Herlev, 2730
About this study
The purpose of this study is to evaluate the effect of calcium electroporation on keloids.
Read the 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.
- Conditions
- Keloid
- Being tested
- Calcium chloride
- Keywords
- Calcium electroporation, calcium, electroporation, electrotransfer, keloid
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium chlorideDrug
Also called Calcium Chloride dihydrate, ATC code A02AC, EV substance codeSUB12664MIG
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Calcium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response evaluated by Vancouver Scar Scale
Vancouver scar scale evaluate the keloids by: pigmentation, pliability, height, and vascularity.
Measured: After 6 months
Secondary outcomes (1)
Adverse events to calcium electroporation.
Describe adverse events using Common Terminology for Adverse Events, version 4.0
Measured: After 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startAug 2013
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeloidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Gehl, Herlev Hospital
- Investigators
- Julie Gehl, MD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941914
- Sponsor's protocol ID
- AA1310
- Status last verified
- Nov 2019
- First submitted
- 3 Sep 2013
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Electroporation for the Treatment of Keloids
- ClinicalTrials.gov ID
- NCT01941914
- Acronym / sponsor ID
- AA1310
- Conditions
- Keloid
- Keywords
- Calcium electroporation, calcium, electroporation, electrotransfer, keloid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calcium electroporation | Experimental | Drug: Calcium chlorideThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium chlorideAlso: Calcium Chloride dihydrate, ATC code A02AC, EV substance codeSUB12664MIG | Drug | Calcium electroporation |
Primary outcome
Response evaluated by Vancouver Scar Scale
Time frame: After 6 months
Vancouver scar scale evaluate the keloids by: pigmentation, pliability, height, and vascularity.
1 secondary outcome
Adverse events to calcium electroporation.
Time frame: After 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Gehl, MD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Calcium chloride in people with Keloid, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response evaluated by Vancouver Scar Scale (time frame: After 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.