Calcium Electroporation for the Treatment of Keloids

Herlev Hospital

Status and phase: Completed; Phase 1

Conditions: Keloid

Treatments: Drug: Calcium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT01941914

AA1310

Details and patient eligibility

About

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

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Calcium electroporation

Experimental group

Description:

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.

Treatment:

Drug: Calcium chloride