Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas

This research study is looking at a combination treatment for people with multiple basal cell carcinoma (BCC) lesions. BCC is a common type of skin cancer. The study is testing Blue-light photodynamic therapy (using a drug called aminolevulinic acid HCL, or ALA, with a BLU-U light device) along with an oral medication called Sonidegib. Typically, BCC is treated by freezing or surgery, which can cause scars. Photodynamic therapy uses light and a skin-applied drug to destroy cancer cells without scarring. Sonidegib is an FDA-approved drug for BCC. The study aims to see how safe and effective this combination treatment is. You may be able to join if you are at least 18 years old and have at least three BCC lesions on your head, neck, trunk, or limbs, measuring 0.5 to 5 cm. The study plans to enroll 20 participants, but its current status is unclear.

Study design: This is an interventional study with an unclear phase, planning to enroll 20 participants. It is testing a combination of Blue-light photodynamic therapy and Sonidegib for basal cell carcinoma.
What's involved: Participants will take Sonidegib daily for 3 months and undergo three photodynamic therapy sessions with topical ALA application at Day 7, Day 45, and Day 75.
Compensation: Not stated in the trial record.
Follow-up: The study will review side effects and measure treatment effectiveness from enrollment to day 180.

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Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas

Recruiting

PHASE1Ages 18+InterventionalTreatment

Nathalie Zeitouni

~20 participants

Updated 2026-01-29 on ClinicalTrials.gov

What's tested:aminolevulinic acid HCL (ALA)BLU-U device model 4170E

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Primary efficacy outcome

Measured over From enrollment to day 180

+1 more outcome measured

Conditions

Basal Cell Carcinoma (BCC)

Where it's being run

1 sites across 1 states

Arizona1

Study leadership

Nathalie Zeitouni, MD · PRINCIPAL_INVESTIGATOR · Medical Dermatology Specialists

Who to contact

Sonja Stutzman Clinical Trial Manager, PhD

[email protected]

214-420-0676

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Childbearing potential refers to a female who has reached menarche, has not had a surgical sterilization procedure (such as a hysterectomy or bilateral oophorectomy), and is not postmenopausal. Menopause is defined as 12 consecutive months of amenorrhea without other biological causes. Furthermore, for females under 55 years old, a serum follicle-stimulating hormone level greater than 40 mIU/mL must be documented to confirm menopause. 2. Sexually active males who are unwilling to use a condom with female partners of childbearing potential, during the study, and for at least 8 months after the last dose of treatment. 3. Subjects who plan on donating blood or blood products during the study and for at least 20 months after the last dose of treatment. Male subjects must agree not to donate sperm during the study and for at least 8 months after the last dose of treatment. 4. Target lesions of basal cell carcinomas of aggressive subtypes (infiltrative, morpheaform, micronodular). 5. Any BCC that may require Mohs surgery for definitive control as a target lesion. 6. Subjects with porphyria's or known hypersensitivity to porphyrins. 7. Subjects with known photosensitivity diseases. 8. Subjects previously treated with a systemic photosensitizer within 4 months of screening date. 9. Subjects who desire to get pregnant a female of childbearing potential within the next 1.5 years. 10. Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 11. Life expectancy less than one year. 12. Inability or unwillingness to swallow capsules. 13. Have a history of alcohol of substance abuse, unless in full remission for greater than 6 months prior to the screening visit (Day 0) when the consent form is signed. 14. Having used any of the following treatment within 6 months before the baseline visit:

hedgehog pathway inhibitor, biologics, or chemotherapy

topical chemotherapy agents including Imiquimod, fluorouracil,) to the selected treatment lesion sites within 3 weeks. 15. Currently undergoing treatment with photodynamic therapy within 3 weeks before baseline visit. 16. Subjects who have received any type of solid organ transplant. 17. Subjects taking immunosuppressive medications at the screening visit that interact with Sonidegib at the screening visit unless approved by the investigator.. 18. Participation in other study using an investigational or experimental therapy or procedure within 4 weeks or 5 half-lives (whichever is longer) before the screening visit and/or during study participation. Subjects cannot participate in studies of other investigational or experimental therapies or procedures at any time during their participation in this study. 19. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 20. Subjects unable or unwilling to comply with the study visit schedule and requirements of the study. 21. Subjects unable to speak and read the English language. 22. A subject who, in the opinion of the sponsor-investigator will be uncooperative or unable to comply with study procedures. 23. A subject who, in the opinion of the sponsor-investigator will be uncooperative or unable to comply with study procedures.

What this trial measures

Primary efficacy outcomeFrom enrollment to day 180
Primary efficacy outcome measure: the overall response rate (ORR) to the combination therapy in patients, which is the proportion of evaluable study subjects who has complete response (CR) or partial response (PR) to the study treatment as defined in the protocol.
Review of AEs likely related to study drugFrom enrollment to day 180
Primary safety outcome measure: the proportion of evaluable study participants who had a grade 3 or higher adverse event (AE) or any serious adverse event (SAE) that determined to be at least possibly or probably related to study treatment, or any AE which is at least possibly or probably related to study treatment that causes permanent study discontinuation. The efficacy outcome measure: the overall response rate (ORR) to the combination therapy in patients, which is the proportion of evaluable study subjects who has complete response (CR) or partial response (PR) to the study treatment.

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