Vismodegib concentration in basal cell carcinoma after laser and vismodegib solution

Biodistribution of ablative fractional laser-assisted topical delivery of Vismodegib in basal cell carcinomas.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002545-38-DK

Enrollment

Registered

2019-06-24

Start date

2019-09-13

Completion date

Unknown

Last updated

2022-04-19

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

Conditions

Basal cell carcinoma Simple nodular basal cell carcinoma at any body locations MedDRA version: 20.0 Level: PT Classification code 10004146 Term: Basal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: LLT Classification code 10066495 Term: Basal cell carcinoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: LLT Cla

Interventions

Trade Name: Erivedge capsules formulated in a cutaneous emulsion to contain 3.8 mg/ml vismodegib. Product Name: Vismodegib Product Code: GDC-0449 Pharmaceutical Form: Cutaneous emulsion INN or Propo

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The study aim is in BCCs exposed to AFL+topical vismodegib to determine 1) intra-tumoral vismodegib concentration and 2) the biologic response of vismodegib expressed by GLI mRNA level at 4 days. These results are compared with BCC-vismodegib concentration in patients undergoing systemic vismodegib treatment.;Secondary Objective: • BCC-vismodegib concentration in patients undergoing systemic vismodegib treatment (150 mg daily) for more than 2 weeks • Reduction in GLI1 mRNA expression in BCCs from baseline in patients undergoing systemic vismodegib treatment (150 mg daily) • Tolerability of laser and topical vismodegib evaluated as a. Local skin reactions evaluated day 4 . b. Plasma total vismodegib concentration day 4. ;Primary end point(s): To investigate the potential of laser and topical vismodegib exposure in BCC evaluated as • BCC vismodegib concentration day 4 after laser and topical vismodegib exposure • Biologic response expressed as GLI1 mRNA level in BCCs, and punch biopsy to determine GLI1 and Ki67 activity investigated by histologic samples at day 4. Baseline GLI1 mRNA activity is determined by 2 mm punch biopsy Each patients will have three 3 mm skin punch bipsies day 4 after AFL-vismodegib incubation. To determine changes in GLI1 mRNA activity, a 2 mm skin punch biopsy is sampled at an inclusion visit held 3-4 weeks before the treatment day. A blood test for total plasma vismodegib is sampled at day 4. ;Timepoint(s) of evaluation of this end point: day 4 after laser and topical vismodegib application	—

Measure

Time frame

Main Objective: The study aim is in BCCs exposed to AFL+topical vismodegib to determine 1) intra-tumoral vismodegib concentration and 2) the biologic response of vismodegib expressed by GLI mRNA level at 4 days. These results are compared with BCC-vismodegib concentration in patients undergoing systemic vismodegib treatment.;Secondary Objective: • BCC-vismodegib concentration in patients undergoing systemic vismodegib treatment (150 mg daily) for more than 2 weeks • Reduction in GLI1 mRNA expression in BCCs from baseline in patients undergoing systemic vismodegib treatment (150 mg daily) • Tolerability of laser and topical vismodegib evaluated as a. Local skin reactions evaluated day 4 . b. Plasma total vismodegib concentration day 4. ;Primary end point(s): To investigate the potential of laser and topical vismodegib exposure in BCC evaluated as • BCC vismodegib concentration day 4 after laser and topical vismodegib exposure • Biologic response expressed as GLI1 mRNA level in BCCs, and punch biopsy to determine GLI1 and Ki67 activity investigated by histologic samples at day 4. Baseline GLI1 mRNA activity is determined by 2 mm punch biopsy Each patients will have three 3 mm skin punch bipsies day 4 after AFL-vismodegib incubation. To determine changes in GLI1 mRNA activity, a 2 mm skin punch biopsy is sampled at an inclusion visit held 3-4 weeks before the treatment day. A blood test for total plasma vismodegib is sampled at day 4. ;Timepoint(s) of evaluation of this end point: day 4 after laser and topical vismodegib application

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Secondary

Measure	Time frame
Secondary end point(s): • BCC-vismodegib concentration in patients undergoing systemic vismodegib treatment (150 mg daily) for more than 2 weeks • Reduction in GLI1 mRNA expression in BCCs from baseline in patients undergoing systemic vismodegib treatment (150 mg daily) • Tolerability of laser and topical vismodegib evaluated as a. Local skin reactions evaluated day 4. b. Plasma total vismodegib concentration day 4. ;Timepoint(s) of evaluation of this end point: day 4 after laser and vismodegib emulsion treatment	—

Measure

Time frame

Secondary end point(s): • BCC-vismodegib concentration in patients undergoing systemic vismodegib treatment (150 mg daily) for more than 2 weeks • Reduction in GLI1 mRNA expression in BCCs from baseline in patients undergoing systemic vismodegib treatment (150 mg daily) • Tolerability of laser and topical vismodegib evaluated as a. Local skin reactions evaluated day 4. b. Plasma total vismodegib concentration day 4. ;Timepoint(s) of evaluation of this end point: day 4 after laser and vismodegib emulsion treatment

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Countries

Denmark

Contacts

Public ContactDepartment of dermatology

Bispebjerg Hospital, Department of Dermatology

katrine.togsverd-bo@regionh.dk004520416746

Outcome results

None listed

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