Vitamin D Effects on Immune Microenvironment of Nonmelanoma Skin Cancer After Photodynamic Therapy (PDT)
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Nonmelanoma Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma
In brief
This research study is for people who have been diagnosed with a nonmelanoma skin cancer (either basal cell carcinoma or squamous cell carcinoma) and are planning to receive either Mohs surgery or ED\&C (electrodessication \& curettage) as part of clinical care. The purpose of this study is to understand how photodynamic therapy (PDT) with or without Vitamin D can promote an immune response to skin cancer. For this study, participants will be randomized (randomly assigned) and asked to take Vitamin D or placebo for 6 days and come to the clinic for a single PDT treatment 1-14 days prior to their surgery. At this visit, photographs of participant's skin cancer will be taken, and participants will undergo PDT treatment. The study team will also take photos on the day of Mohs surgery or ED\&C. There will be up to two blood draws for research. If participants do not want to come in for a PDT treatment prior to their Mohs surgery or ED\&C, they will have the option to participate by only allowing the study team to collect data about their skin cancer and their tissue from Mohs surgery or ED\&C.
Key facts
- Study ID
- NCT07241585
- Run by
- Case Comprehensive Cancer Center
- People needed
- 54
- Starts
- 2026-02-25
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-06-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Must be an adult participant (> 18 yrs) who is scheduled to undergo Mohs surgery or ED\&C within the Dermatologic Surgery unit of the Department of Dermatology, Cleveland Clinic.
- Must have at least one BCC or SCC tumor eligible for removal by Mohs surgery.
- The original tumor size prior to biopsy must be >1.0 cm (in the longest diameter).
- Participants of any ethnic group are eligible for this trial.
- Must provide informed consent to participate in the trial.
- Participant must live in Ohio (Groups 2 \& 3), because Research Pharmacy cannot ship the study drugs outside of the state.
You may not qualify if…
- Pregnant or breastfeeding
- Currently being treated for other cancers with medical or radiation therapy
- Known hypersensitivity to 5-aminolevulinic acid
- History of a photosensitivity disease, e.g., porphyria cutanea tarda
Where it is running
- Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute — Cleveland, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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