delta-Aminolevulinic acid and blue light photodynamic therapy for treatment of multiple basal cell carcinomas in two patients with nevoid basal cell carcinoma syndrome.
Aleksandr Itkin, Barbara A Gilchrest
https://pubmed.ncbi.nlm.nih.gov/15209801Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID06623201
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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Blue-Light Photodynamic Therapy (PDT) and Sonidegib as a possible treatment for people with multiple basal cell carcinoma (BCC) lesions. This study focuses on participants who have at least three nodular BCC lesions and aims to assess the safety and effectiveness of this approach compared to standard treatments like freezing or surgery, which can cause scarring. Sonidegib is an FDA-approved oral drug for BCC, and PDT uses a special blue light with a topical drug to target cancer cells without causing scarring. Participants will take Sonidegib 200 mg orally every day on an empty stomach for three months. They will also receive three sessions of PDT, where the drug aminolevulinic acid (ALA) is applied to the skin lesions and then activated by blue light using a BLU-U device. These PDT sessions occur on Day 7, Day 45, and Day 75. The light treatment may cause warmth or stinging sensations but is not expected to cause scarring. During the study, participants will undergo regular evaluations including monitoring for side effects possibly related to the study drug and assessments of disease progression. The primary outcomes will be reviewed from enrollment through day 180. Participants will also have blood tests and clinical exams to check liver, kidney, and blood function. The total study duration is about six months, with treatment and follow-up visits scheduled to closely monitor safety and response to the combination therapy.
CONDITIONS
Brief Title
Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older
- Diagnosed with 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 sooner than 2 weeks before treatment
- Patients with high disease burden who are non-surgical candidates or refuse surgery
- Patients unable to tolerate extensive surgery or with many comorbidities
- Patients for whom surgery or radiation therapy is impractical
- Primary lesions may be eligible
- Normal or clinically acceptable blood, liver, and kidney function
- Ability and willingness to provide signed informed consent in English
You will not qualify if you...
- Sexually active women of childbearing potential unwilling to use highly effective contraception during and after the study
- Sexually active males unwilling to use condoms during and after the study
- Planning to donate blood, blood products, or sperm during and after the study
- Aggressive basal cell carcinoma subtypes as target lesions
- Lesions requiring Mohs surgery for control
- History of 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 including infections, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- Life expectancy less than one year
- Inability or unwillingness to swallow capsules
- History of alcohol or substance abuse not in full remission for over 6 months
- Recent use (within 6 months) of hedgehog pathway inhibitors, biologics, chemotherapy, or topical chemotherapy agents on target lesions
- 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
- Severe medical or psychiatric conditions increasing risk or interfering with results
- Inability or unwillingness to comply with study visits or requirements
- Unable to read and speak English
- Deemed uncooperative or unable to comply with procedures by sponsor-investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 months
Participants receive Sonidegib 200 mg by mouth daily for 3 months and undergo three photodynamic therapy sessions with topical application of ALA on Day 7, Day 45, and Day 75.
5 in-person visits including 3 PDT sessions on Day 7, Day 45, and Day 75
Follow-up
Duration - Up to 3 months after treatment ends
Participants are monitored for safety and efficacy outcomes up to Day 180 after enrollment.
Visits as scheduled up to Day 180
Trial Site Locations
Total: 1 location
1
Medical Dermatology Specialists
Phoenix, Arizona, United States, 85006
Actively Recruiting
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Research Team
S
Sonja Stutzman Clinical Trial Manager, PhD
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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Published Research Related To This Trial
Blue light versus red light for photodynamic therapy of basal cell carcinoma in patients with Gorlin syndrome: A bilaterally controlled comparison study.
Edward V Maytin, Urvashi Kaw, Muneeb Ilyas...
https://pubmed.ncbi.nlm.nih.gov/29471147Basal Cell Carcinoma: A Comprehensive Review of Existing and Emerging Nonsurgical Therapies.
Julien Lanoue, Gary Goldenberg
https://pubmed.ncbi.nlm.nih.gov/27386043Basal cell carcinomas: attack of the hedgehog.
Ervin H Epstein
https://pubmed.ncbi.nlm.nih.gov/18813320