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

NCT06623201 | Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: PDT-MDS-BCC-24
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Basal Cell Carcinoma (BCC)

Keywords

Basal cell carcinoma; Levulan; PDT

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From enrollment to day 180

Secondary Outcomes (1)

• Review of disease progression

  From enrollment to day 180

Study Arms (1)

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).

Drug: aminolevulinic acid HCL (ALA); Device: BLU-U device model 4170E

Interventions

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.

Blue-Light Photodynamic Therapy and Sonidegib

BLU-U device model 4170E DEVICE

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.

Blue-Light Photodynamic Therapy and Sonidegib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Nathalie Zeitouni: lead

Study Sites (1)

Medical Dermatology Specialists

Phoenix, Arizona, 85006, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 15209801 BACKGROUND

• 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.

  PMID: 29471147 BACKGROUND

• 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.

  PMID: 27386043 BACKGROUND

• Epstein EH. Basal cell carcinomas: attack of the hedgehog. Nat Rev Cancer. 2008 Oct;8(10):743-54. doi: 10.1038/nrc2503.

  PMID: 18813320 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Nathalie Zeitouni, MD

  Medical Dermatology Specialists

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonja Stutzman Clinical Trial Manager, PhD

CONTACT

214-420-0676; sstutzman@usdermpartners.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: Open-label study where all participants receive the same treatment

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: October 7, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (1)