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

Conditions

• Basal Cell Carcinoma (BCC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Oct 7, 2024

Status verified

Jan 2026

Primary completion

Dec 1, 2026

Completion

Dec 1, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Blue-Light Photodynamic Therapy and Sonidegib
  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).

Primary Outcome Measure

Primary efficacy outcome [ Time Frame: From enrollment to day 180 ]

Central Contacts

• Sonja Stutzman Clinical Trial Manager, PhD
  214-420-0676
  [email protected]

Locations (1)

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