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

NCT06623201 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-29

No results posted yet for this study

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.

Conditions

  • Basal Cell Carcinoma (BCC)

Interventions

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.

Sponsors & Collaborators

  • Nathalie Zeitouni

    lead OTHER

Principal Investigators

  • Nathalie Zeitouni, MD · Medical Dermatology Specialists

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-07
Primary Completion
2026-12-01
Completion
2026-12-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06623201 on ClinicalTrials.gov