Blue-Light Therapy + Sonidegib for Basal Cell Carcinoma

Palo Alto (17 mi)

Overseen byNathalie Zeitouni, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Nathalie Zeitouni

No Placebo Group

Trial Summary

What is the purpose of this trial?This research study is testing combination Blue-light photodynamic therapy and Sonidegib as a possible treatment for people with multiple basal cell carcinoma lesions. Basal cell carcinoma lesions are typically treated by freezing the lesion or surgically removing the lesion. These types of treatment can cause scarring. Photodynamic therapy uses light along with a drug applied to the skin to kill the cancer cells and cause them to break apart. The light used can cause the skin to feel warm, but does not cause scarring.

Eligibility Criteria

This trial is for individuals with multiple basal cell carcinoma lesions, a common type of skin cancer. It's aimed at those who seek an alternative to freezing or surgical removal, which can leave scars.

Inclusion Criteria

I am a man or a woman unable to have children, and I am 18 or older.

I have basal cell carcinoma with 3 or more nodules on my head, neck, trunk, or limbs.

Exclusion Criteria

I have an aggressive type of skin cancer.

My skin cancer might need Mohs surgery for complete removal.

I am currently taking medication that affects my immune system.

I have a condition that makes my skin unusually sensitive to sunlight.

I am known to have HIV, hepatitis B, or hepatitis C.

I haven't used specific cancer treatments like hedgehog inhibitors, biologics, or chemotherapy in the last 6 months.

I do not have any severe illnesses or social situations that would stop me from following the study rules.

I am currently receiving photodynamic therapy.

Treatment Details

The study tests combining Blue-light photodynamic therapy (using the BLU-U device and a drug called ALA) with Sonidegib medication to treat skin cancer without scarring.

1Treatment groups

Experimental Treatment

Group I: Blue-Light Photodynamic Therapy and SonidegibExperimental Treatment2 Interventions

All subjects will receive Sonidegib (ODOMZO) 200mg by mouth every day on an empty stomach (1 hour before or 2 hours after a meal) for 3 months, and PDT with topical application of ALA for a total of 3 sessions. PDT will be first administered at Visit 3 (Day 7), Visit 4 (Day 30), and Visit 5 (Day 90).