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aser immunotherapy with and without topical anti-PD1 in basal cell carcinomas - Laser immunotherapy and topical anti-PD1

Phase 1
Conditions
Basal cell carcinoma in 24-30 patients
Therapeutic area: Diseases [C] - Cancer [C04]
Registration Number
EUCTR2019-003310-14-DK
Lead Sponsor
Department of Dermatology, Bispebjerg Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
20
Inclusion Criteria

•Patients 18 years or older
•Histologically verified BCC, irrespective of histologic subtype with diameter =7 mm at baseline.
•Signed informed consent.
•Female subjects of childbearing potential* must be confirmed not pregnant by a negative pregnancy test prior to study treatment and must use a safe contraceptive method.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•Concomitant treatment with 5-FU or imiquimod
•Concomitant chemotherapeutic treatment
•Concomitant systemic immunotherapeutic treatment
•Pregnant or lactating women
•Allergies to anti-PD1
•Patients with a tendency to form keloids
•Other skin diseases or tattoos in the treatment area.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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