Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas
NCT ID: NCT06623201
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2024-10-07
2026-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Photodynamic Therapy and Vismodegib for Multiple Basal Cell Carcinomas
NCT02639117
MRI-Guided Focused Ultrasound Radiosensitization for Patients With Malignant Melanoma and Non Melanoma Skin Cancer
NCT05620290
Treatment of Basal Cell Carcinoma (BCC) of the Skin, of the Morpheiform, Infiltrative, and Noduloulcerative Types in Inoperable Patients and Not Suitable for Radiotherapy Using Formulated Methylene Blue
NCT07311070
Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma
NCT04552990
Superficial Basal Cell Carcinoma Treatment With Topical Photodynamic Therapy With Fractionated 5-aminolevulinic Acid 20% Versus Two Stage Methylaminolevulinate
NCT01491711
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The drug applied to the skin before the light treatment is an FDA approved drug called Levulan and has no known side effects. The light used to treat the lesion is blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator (Levulan-PDT). This treatment regimen is approved by the FDA to treat actinic keratoses, but is not approved to treat basal cell carcinoma. Use of the light can feel warm and may sting.
Sonidegib (Odomzo) is a compound that was approved by the US Food and Drug Administration in July 2015 as a treatment option for BCC. Patients on Sonidegib may experience leg cramps, taste disturbance, or alopecia
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Blue-Light Photodynamic Therapy and Sonidegib
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).
aminolevulinic acid HCL (ALA)
Prior to ALA application, the areas will be cleaned with alcohol and debrided gently with prep tape. ALA will then be applied to each of the study lesions and allowed to incubate for 3 hours with occlusion prior to the PDT.
BLU-U device model 4170E
Participants will be subjected to dose illumination with blue light (BLU-U Model 4170E) at a power fluence of 20 mW/cm2 for a total time of 16 minutes and 40 seconds (1,000 seconds). This will result in a total light delivery dose of 20 J/cm2.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
aminolevulinic acid HCL (ALA)
Prior to ALA application, the areas will be cleaned with alcohol and debrided gently with prep tape. ALA will then be applied to each of the study lesions and allowed to incubate for 3 hours with occlusion prior to the PDT.
BLU-U device model 4170E
Participants will be subjected to dose illumination with blue light (BLU-U Model 4170E) at a power fluence of 20 mW/cm2 for a total time of 16 minutes and 40 seconds (1,000 seconds). This will result in a total light delivery dose of 20 J/cm2.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
1. 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:
1. 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
2. Intrauterine device (IUD); intrauterine hormone-releasing system
3. Bilateral tubal ligation;
4. Vasectomized partner (provided that the vasectomized partner is the sole sexual partner of the WOCBP study subject);
5. 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.
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. Basal cell carcinomas of aggressive subtypes (infiltrative, morpheaform, micronodular)
5. Any BCC that may require Mohs surgery for definitive control
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. Known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C viruses.
15. 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
16. Currently undergoing treatment with photodynamic therapy within 3 weeks before baseline visit
17. Subjects who have received any type of solid organ transplant
18. Subjects taking immunosuppressive medications at the screening visit.
19. 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.
20. 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.
21. Subjects unable or unwilling to comply with the study visit schedule and requirements of the study
22. Subjects unable to speak and read the English language
23. A subject who, in the opinion of the sponsor-investigator will be uncooperative or unable to comply with study procedures.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nathalie Zeitouni
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nathalie Zeitouni
Sponsor-Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nathalie Zeitouni, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Dermatology Specialists
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical Dermatology Specialists
Phoenix, Arizona, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Itkin A, Gilchrest BA. delta-Aminolevulinic acid and blue light photodynamic therapy for treatment of multiple basal cell carcinomas in two patients with nevoid basal cell carcinoma syndrome. Dermatol Surg. 2004 Jul;30(7):1054-61. doi: 10.1111/j.1524-4725.2004.30317.x.
Maytin EV, Kaw U, Ilyas M, Mack JA, Hu B. Blue light versus red light for photodynamic therapy of basal cell carcinoma in patients with Gorlin syndrome: A bilaterally controlled comparison study. Photodiagnosis Photodyn Ther. 2018 Jun;22:7-13. doi: 10.1016/j.pdpdt.2018.02.009. Epub 2018 Feb 19.
Lanoue J, Goldenberg G. Basal Cell Carcinoma: A Comprehensive Review of Existing and Emerging Nonsurgical Therapies. J Clin Aesthet Dermatol. 2016 May;9(5):26-36. Epub 2016 May 1.
Epstein EH. Basal cell carcinomas: attack of the hedgehog. Nat Rev Cancer. 2008 Oct;8(10):743-54. doi: 10.1038/nrc2503.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PDT-MDS-BCC-24
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.