NCT06623201

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Nathalie Zeitouni · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Basal Cell Carcinoma (BCC)

Interventions

Type	Name	Description
DRUG	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.
DEVICE	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.

Timeline

• Start date: 2024-10-07
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-10-02
• Last updated: 2026-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study