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

Phase 1

Not yet recruiting

• Conditions: Basal Cell Carcinoma (BCC)
• Interventions: Drug: aminolevulinic acid HCL (ALA); Device: BLU-U device model 4170E

• Registration Number: NCT06623201
• Lead Sponsor: Nathalie Zeitouni

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.

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 30, and Day 90.

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 Timeline

• Study First Submitted: 2024-09-30
• Study First Submitted QC: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-03
• Study Start: 2024-12-01
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blue-Light Photodynamic Therapy and Sonidegib	aminolevulinic acid HCL (ALA)	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 30), and Visit 5 (Day 90).
Blue-Light Photodynamic Therapy and Sonidegib	BLU-U device model 4170E	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 30), and Visit 5 (Day 90).

Primary Outcome Measures

Name	Time	Method
Primary efficacy outcome	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	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, as defined in Section 5.1) that\'s 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.

Secondary Outcome Measures

Name	Time	Method
Review of disease progression	From enrollment to day 180	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).

Trial Locations

Locations (1)

Medical Dermatology Specialists; 🇺🇸 Phoenix, Arizona, United States