Calcium electroporation for treatment of skin cancer

Calcium electroporation for basal cell carcinomas – a ’Proof of concept’ study - CaEP for BCC

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002730-36-DK

Enrollment

Registered

2019-07-04

Start date

2019-11-14

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basal cell carcinomas MedDRA version: 21.1 Level: LLT Classification code 10042503 Term: Superficial basal cell carcinoma System Organ Class: 100000004864 MedDRA version: 21.1 Level: LLT Classification code 10073093 Term: Nodular basal cell carcinoma System Organ Class: 100000004864

Interventions

Trade Name: Calciumchlorid ”SAD” Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Calcium SAD Other descriptive name: CA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients > 18 years of age Biopsi proven primary low risk basal cell carcinom less than 3 cm in diameter Oral and written consent before inclusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 13 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: Basal cell carcinomas on the tip of the nose, eye lids, ears, lips and scalp Recurrent lesions Organ transplantation or immunosuppression Pregnant or breast feeding Allergy to local anesthetics

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Clinical tumor response by dermatologist and OCT guided biopsy;Timepoint(s) of evaluation of this end point: 3 months after last treatment;Main Objective: Efficacy of calcium electroporation in the treatment of primary low risk basal cell carcinomas; Secondary Objective: Side effects after treatment (erythema, pain, oedema and ulceration) 1 year recurrence rate Cosmetic outcome 3 and 12 months after treatment	—

Measure

Time frame

Primary end point(s): Clinical tumor response by dermatologist and OCT guided biopsy;Timepoint(s) of evaluation of this end point: 3 months after last treatment;Main Objective: Efficacy of calcium electroporation in the treatment of primary low risk basal cell carcinomas; Secondary Objective: Side effects after treatment (erythema, pain, oedema and ulceration) 1 year recurrence rate Cosmetic outcome 3 and 12 months after treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Side effects after treatment 1 year recurrence rate Cosmetic outcome ; Timepoint(s) of evaluation of this end point: Side effects: 2-12 weeks, 3 and 12 months Recurrence rate: 1 year Cosmetic outcome: 3 and 12 months	—

Countries

Denmark

Contacts

Public ContactStine Regin Wiegell

Department of Dermatology, Bispebjerg Hospital

stine.regin.wiegell@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026