Actively Recruiting
Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas
Led by Nathalie Zeitouni · Updated on 2026-01-29
20
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, at least 18 years old
- Diagnosis of basal cell carcinoma with at least 3 nodular lesions measuring 0.5 cm to 5 cm on the head, neck, trunk, or extremities
- Diagnosis confirmed clinically at baseline with 1-3 lesions biopsied no earlier than 2 weeks before treatment
- Patients with large disease burden, non-surgical candidates, or those refusing surgery
- Non-surgical candidates who may tolerate removal of a single lesion but not extensive surgery
- Patients for whom surgery or radiation therapy may be impractical
- Primary lesions are acceptable for enrollment
- Normal or clinically acceptable hematopoietic, liver, and kidney function
- Signed informed consent and willingness to understand and sign written consent in English
You will not qualify if you...
- Sexually active women of childbearing potential unwilling to use highly effective contraception before and during the study and for 20 months after the final dose
- Sexually active males unwilling to use condoms with female partners of childbearing potential during the study and for 8 months after last dose
- Planning to donate blood or sperm during the study and for specified periods afterwards
- Basal cell carcinomas of aggressive subtypes (infiltrative, morpheaform, micronodular)
- Lesions requiring Mohs surgery
- Known porphyria or hypersensitivity to porphyrins
- Known photosensitivity diseases
- Previous systemic photosensitizer treatment within 4 months
- Desire to become pregnant within 1.5 years
- Uncontrolled illnesses or conditions limiting compliance
- Life expectancy less than one year
- Inability or unwillingness to swallow capsules
- History of substance abuse unless in remission for over 6 months
- Recent use of hedgehog inhibitors, biologics, chemotherapy, or topical chemotherapy agents within specified timeframes
- Recent photodynamic therapy within 3 weeks before baseline
- History of solid organ transplant
- Use of immunosuppressive medications interacting with Sonidegib unless approved
- Participation in other investigational studies within 4 weeks or 5 half-lives before screening or during this study
- Other severe medical or psychiatric conditions that increase risk or interfere with study
- Inability or unwillingness to comply with study visits and requirements
- Inability to speak and read English
- Deemed uncooperative or unable to comply by the sponsor-investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical Dermatology Specialists
Phoenix, Arizona, United States, 85006
Actively Recruiting
Research Team
S
Sonja Stutzman Clinical Trial Manager, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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