Vismodegib concentration in basal cell carcinoma after laser and vismodegib solutio

Phase 1

• Conditions: Basal cell carcinomaSimple nodular basal cell carcinoma at any body locations; MedDRA version: 21.1Level: LLTClassification code 10073093Term: Nodular basal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10004146Term: Basal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10066495Term: Basal cell carcinoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-002545-38-DK
• Lead Sponsor: Bispebjerg Hospital, Department of Dermatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-24
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

•Patients above 18 years of age
•Clinically and histologically verified nodular BCC with diameter =8 mm at baseline.
•Signed informed consent.
•Female subjects of childbearing potential1 must be confirmed not pregnant by a negative pregnancy test prior to study treatment and must use a safe contraceptive method for 24 months after study participation.
•Patients with multiple BCC or locally advanced BCC in continuous oral vismodegib treatment (150 mg per day) for at least 14 days.
•Male subjects with female partners of childbearing potential must use condom until 2 months after study participation.

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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

•Concomittant treatment with itraconazole, ketoconazole or imiquimod.
•Concomittant chemotherapeutic treatment.
•Infiltrative BCC or basosquamous carcinoma.
•Pregnant or lactating women.
•Allergies to vismodegib.
•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