Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas
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.
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 approv…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 selecte…
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.
Location
- Medical Dermatology SpecialistsPhoenix, Arizona