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Vitamin D and Photodynamic Therapy for Nonmelanoma Skin Cancer

This study is for adults with nonmelanoma skin cancer (basal cell carcinoma or squamous cell carcinoma) who are already scheduled for Mohs surgery or ED&C (electrodessication & curettage). Researchers want to see if adding Vitamin D to photodynamic therapy (PDT) can boost the body's immune response against skin cancer. You would take Vitamin D or a placebo (inactive pill) for 6 days before a single PDT treatment. PDT involves applying a special cream (aminolevulinate or ALA) to your tumor, then shining a blue light on it. The main goal is to measure how immune checkpoint molecules are expressed in your tumor after PDT, which helps understand the immune response. This study is currently unclear on its recruitment status and plans to enroll 54 participants.

Study design
This is an interventional study where participants will be randomly assigned to receive Vitamin D or a placebo, and will be blinded to which they receive. It aims to enroll 54 participants.
What's involved
You would take a capsule daily for 6 days, then have a single PDT treatment 1-14 days before your planned Mohs surgery or ED&C. Photographs of your skin cancer will also be taken.
Compensation
Not stated in the trial record.
Follow-up
Immune checkpoint molecules will be measured at the time of Mohs surgery or ED&C, up to Day 20.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07241585

Vitamin D Effects on Immune Microenvironment of Nonmelanoma Skin Cancer After Photodynamic Therapy (PDT)

Recruiting
NAAges 18+InterventionalBasic science
Case Comprehensive Cancer Center
~54 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Vitamin D (VitD)PlaceboPhotodynamic therapy (PDT)Mohs surgery or electrodessication & curettage (ED&C) (standard of care)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Expression of immune checkpoint molecules
Measured over At time of Mohs surgery or ED&C, up to Day 20

Conditions

Nonmelanoma Skin Cancer
Basal Cell Carcinoma
Squamous Cell Carcinoma

Explore related trials

Basal Cell CarcinomaSkin CarcinomaSquamous Cell Carcinoma

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Edward Maytin, MD, PhD · PRINCIPAL_INVESTIGATOR · Case Comprehensive Cancer Center, Cleveland Clinic

Who to contact

Edward Maytin, MD, PhD
[email protected]
(216) 346-6022
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • Expression of immune checkpoint moleculesAt time of Mohs surgery or ED&C, up to Day 20

    Expression of immune checkpoint molecules will be compared in tumors and peri-tumoral stroma after photodynamic therapy (PDT) versus tumors without PDT and is defined as changes in the expression of PD-1, PD-L1, and TIM3, among other checkpoint inhibitors. This will be measured using the scRNA-seq data obtained from tumor tissues via Parse Biosciences scRNA-seq analysis.