RecruitingPhase 1NCT06623201

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


Sponsor

Nathalie Zeitouni

Enrollment

20 participants

Start Date

Oct 7, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of blue-light photodynamic therapy (a light-activated treatment) and sonidegib (a targeted oral drug) for people with multiple basal cell carcinoma (BCC) skin lesions. BCC is a common type of skin cancer, and this study is designed for patients who have multiple lesions and are not good candidates for surgery. **You may be eligible if...** - You are 18 or older - You have at least 3 nodular BCC lesions (each between 0.5 and 5 cm) on the head, neck, trunk, or limbs - Your diagnosis has been confirmed clinically, with 1–3 lesions biopsied - You are not a surgical candidate, or surgery would be risky, impractical, or disfiguring - You have not had prior treatment for these lesions **You may NOT be eligible if...** - You have only a single BCC lesion that can be easily removed - You have been previously treated with a hedgehog pathway inhibitor - You have serious health conditions that make you ineligible for either treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGaminolevulinic 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.

DEVICEBLU-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.


Locations(1)

Medical Dermatology Specialists

Phoenix, Arizona, United States

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NCT06623201


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