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

Recruiting now · Phase 1

Conditions studied: Basal Cell Carcinoma (BCC)

In brief

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.

Key facts

Study ID

NCT06623201

Run by

Nathalie Zeitouni

People needed

20

Starts

2024-10-07

Expected to finish

2026-12-01

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients will be excluded from the study based on the following criteria:
• Sexually active women of childbearing (WOCBP)* who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for 20 months after the final dose of treatment. Highly effective contraceptive measures include:
• Stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation
• Intrauterine device (IUD); intrauterine hormone-releasing system
• Bilateral tubal ligation;
• Vasectomized partner (provided that the vasectomized partner is the sole sexual partner of the WOCBP study subject);
• and/or sexual abstinence.
• 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.
• 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.
• 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.
• Target lesions of basal cell carcinomas of aggressive subtypes (infiltrative, morpheaform, micronodular).
• Any BCC that may require Mohs surgery for definitive control as a target lesion.
• Subjects with porphyria's or known hypersensitivity to porphyrins.
• Subjects with known photosensitivity diseases.
• Subjects previously treated with a systemic photosensitizer within 4 months of screening date.
• Subjects who desire to get pregnant a female of childbearing potential within the next 1.5 years.
• 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.
• Life expectancy less than one year.
• Inability or unwillingness to swallow capsules.
• 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.
• 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.
• Currently undergoing treatment with photodynamic therapy within 3 weeks before baseline visit.
• Subjects who have received any type of solid organ transplant.

Where it is running

• Medical Dermatology Specialists — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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