Loading clinical trials...

Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT06623201•Nathalie Zeitouni

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.

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients will be included in the study based on the following criteria:
•1. Male or females, at least 18 years of age.
•2. Diagnosis of BCC with at least 3 nodular lesions that measure 0.5 cm to 5 cm in diameter, located on the head and neck, trunk or extremities.
•3. Diagnosis must be confirmed clinically at baseline with 1-3 lesions having been biopsied no sooner than 2 weeks prior to treatment.
•4. Patients who may have high burden of disease (i.e., large lesions), who are non-surgical candidates or who refuse surgery.
•5. Non-surgical candidates, who may be able to undergo resection of selected single, individual lesion, but may not tolerate extensive surgery, may have many co morbidities, may be prone to complications.
•6. Patients in whom surgery or radiation therapy may be impractical.
•7. Primary lesions may be acceptable for enrollment.
•8. Within normal limit hematopoietic capacity, hepatic and renal function. Values outside those limits may be allowed at the discretion of the PI, if they are determined as not clinically significant.
•9. Evidence of a personally signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial.
+1 more criteria

Exclusion Criteria

•Patients will be excluded from the study based on the following 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.
+22 more criteria

Locations (1)

Medical Dermatology Specialists

Phoenix, Arizona, United States

Key Dates

Start Date

October 7, 2024

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

January 29, 2026

Enrollment

ESTIMATED participants

Conditions

Basal Cell Carcinoma (BCC)

Interventions

aminolevulinic acid HCL (ALA)

DRUG

BLU-U device model 4170E

DEVICE

Contacts

Sonja Stutzman Clinical Trial Manager, PhD

CONTACT

214-420-0676 sstutzman@usdermpartners.com

Impact of Preoperative High-Frequency Ultrasound Cutaneous Lesion Extent Assessment on Excision Margin Positivity in Head and Neck Skin Cancer, and the Relationship Between Preoperative Assessment Methods, Inadequate Excision Margins, and Tumor Recurrence

NCT07361666

Basal Cell Carcinoma of SkinCutaneous Squamous Cell Carcinoma (CSCC)+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions