Basal Cell Carcinoma (BCC)Phase 1NCT06623201
Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas
A Phase 1 study testing aminolevulinic acid HCL (ALA) and BLU-U device model 4170E in people with Basal Cell Carcinoma (BCC), run by Nathalie Zeitouni at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma (BCC)
- What is being tested?
- aminolevulinic acid HCL (ALA) and BLU-U device model 4170E
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2024to 1 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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);
Show all 32Show fewer
- 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.
- Subjects taking immunosuppressive medications at the screening visit that interact with Sonidegib at the screening visit unless approved by the investigator..
- 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.
- 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.
- Subjects unable or unwilling to comply with the study visit schedule and requirements of the study.
- Subjects unable to speak and read the English language.
- A subject who, in the opinion of the sponsor-investigator will be uncooperative or unable to comply with study procedures.
- A subject who, in the opinion of the sponsor-investigator will be uncooperative or unable to comply with study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical Dermatology Specialists
Phoenix, Arizona, 85006
Stephen Dietrich, BA, 602.354.5770 ext. 4276, sdietrich@usdermpartners.com
Hadyn Harbaugh, BA, 602.354.5770 ext. 4276, hharbaugh@usdermpartners.com
About this study
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.
Read the detailed description
Blue light PDT has shown some success in treating BCCs, but more research is needed to evaluate this treatment modality further. The objective of this study is to evaluate the safety and efficacy of using photodynamic Therapy with Sonidegib for the treatment of multiple nodular basal cell carcinomas. Participants who meet eligibility criteria at baseline will receive Sonidegib 200 mg by mouth every day for 3 months. Participants will undergo three PDT sessions with topical application of ALA at Day 7, Day 45, and Day 75.
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
- Basal Cell Carcinoma (BCC)
- Being tested
- aminolevulinic acid HCL (ALA), BLU-U device model 4170E
- Keywords
- Basal cell carcinoma, Levulan, PDT
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aminolevulinic acid HCL (ALA)Drug
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 4170EDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Blue-Light Photodynamic Therapy and Sonidegib | Experimental | 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 45), and Visit 5 (Day 75). Receives: Drug: aminolevulinic acid HCL (ALA); Device: BLU-U device model 4170E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy outcome
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.
Measured: From enrollment to day 180
Review of AEs likely related to study drug
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.
Measured: From enrollment to day 180
Secondary outcomes (1)
Review of disease progression
The secondary efficacy outcome measures: the proportion of evaluable subjects with progressive disease (PD), and the proportion of evaluable subjects with stable disease (SD). The proportion of evaluable study subjects who have complete histological clearance (CHC). The secondary safety outcome measures: the proportion of evaluable subjects who have AE of any specific grade or any specific type, or any SAE.
Measured: From enrollment to day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start7 Oct 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Basal Cell Carcinoma (BCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label study where all participants receive the same treatment
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nathalie Zeitouni
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nathalie Zeitouni, US Dermatology Partners, Phoenix
- Investigators
- Nathalie Zeitouni, MD, Principal investigator, Medical Dermatology Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623201
- Sponsor's protocol ID
- PDT-MDS-BCC-24
- Status last verified
- Jan 2026
- First submitted
- 30 Sep 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Contractual obligations with SunPharma
Publications
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.
PubMed 15209801Maytin 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.
PubMed 29471147Lanoue 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.
PubMed 27386043Epstein EH. Basal cell carcinomas: attack of the hedgehog. Nat Rev Cancer. 2008 Oct;8(10):743-54. doi: 10.1038/nrc2503.
PubMed 18813320
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas
- ClinicalTrials.gov ID
- NCT06623201
- Acronym / sponsor ID
- PDT-MDS-BCC-24
- Conditions
- Basal Cell Carcinoma (BCC)
- Keywords
- Basal cell carcinoma, Levulan, PDT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nathalie ZeitouniUniversity, hospital or other
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Blue light PDT has shown some success in treating BCCs, but more research is needed to evaluate this treatment modality further. The objective of this study is to evaluate the safety and efficacy of using photodynamic Therapy with Sonidegib for the treatment of multiple nodular basal cell carcinomas. Participants who meet eligibility criteria at baseline will receive Sonidegib 200 mg by mouth every day for 3 months. Participants will undergo three PDT sessions with topical application of ALA at Day 7, Day 45, and Day 75.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label study where all participants receive the same treatment
| Arm | Type | Receives |
|---|---|---|
| Blue-Light Photodynamic Therapy and Sonidegib | Experimental | Drug: aminolevulinic acid HCL (ALA), Device: BLU-U device model 4170EAll 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 45), and Visit 5 (Day 75). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (32 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Blue-Light Photodynamic Therapy and Sonidegib |
| BLU-U device model 4170EParticipants 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. | Device | Blue-Light Photodynamic Therapy and Sonidegib |
Primary outcome
Primary efficacy outcome
Time frame: From 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 drug
Time frame: From 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.
1 secondary outcome
Review of disease progression
Time frame: From enrollment to day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Background: PubMed 15209801Itkin 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.
- Background: PubMed 29471147Maytin 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.
- Background: PubMed 27386043Lanoue 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.
- Background: PubMed 18813320Epstein EH. Basal cell carcinomas: attack of the hedgehog. Nat Rev Cancer. 2008 Oct;8(10):743-54. doi: 10.1038/nrc2503.
- Individual participant dataSharing planned: Undecided. Contractual obligations with SunPharma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathalie Zeitouni, MD principal investigator
Medical Dermatology Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing aminolevulinic acid HCL (ALA) and BLU-U device model 4170E in people with Basal Cell Carcinoma (BCC), run by Nathalie Zeitouni at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sonja Stutzman Clinical Trial Manager, PhD (214-420-0676, sstutzman@usdermpartners.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy outcome (time frame: From enrollment to day 180). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06623201, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.