Calcium electroporation for treatment of skin cancer
Phase 1
- Conditions
- Basal cell carcinomasMedDRA version: 21.1 Level: LLT Classification code 10042503 Term: Superficial basal cell carcinoma System Organ Class: 100000004864MedDRA version: 21.1 Level: LLT Classification code 10073093 Term: Nodular basal cell carcinoma System Organ Class: 100000004864Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2019-002730-36-DK
- Lead Sponsor
- Department of Dermatology, Bispebjerg Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 25
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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;<br> Secondary Objective: Side effects after treatment (erythema, pain, oedema and ulceration)<br> 1 year recurrence rate<br> Cosmetic outcome 3 and 12 months after treatment<br>
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): Side effects after treatment<br> 1 year recurrence rate<br> Cosmetic outcome<br> ;<br> Timepoint(s) of evaluation of this end point: Side effects: 2-12 weeks, 3 and 12 months<br> Recurrence rate: 1 year<br> Cosmetic outcome: 3 and 12 months<br>