Recruiting

PDT with Vitamin D

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT07241585

Conditions

Nonmelanoma Skin Cancer

Basal Cell Carcinoma

Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vitamin D (VitD)

Placebo

Photodynamic therapy (PDT)

Mohs surgery or electrodessication & curettage (ED&C) (standard of care)

Study Details

Brief summary:

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.

Conditions

Nonmelanoma Skin Cancer

Basal Cell Carcinoma

Squamous Cell Carcinoma

Study ID

NCT07241585

Start date

Feb 25, 2026

Status verified date

Aug, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Arm 1: Participants donate discarded tissue for research (No VitD/Placebo + no PDT)

Participants in Arm 1 will donate discarded tissue from their scheduled standard of care Mohs surgery or ED\&C. They will not be randomized to receive VitD or placebo and will not have PDT.

experimental: Arm 2: VitD + PDT prior to Mohs surgery or ED&C

Participants in Arms 2 and 3 will be randomized to receive either VitD or placebo prior to PDT and Mohs surgery or ED\&C visit.

placebo comparator: Arm 3: Placebo + PDT prior to Mohs surgery or ED&C

Participants in Arms 2 and 3 will be randomized to receive either VitD or placebo prior to PDT and Mohs surgery or ED\&C visit.

Interventions

Vitamin D (VitD)

Participants will orally take 10,000 international units daily of VitD for the 6 days prior to their scheduled PDT visit. Participants in Arms 2 and 3 will be blinded to whether they are receiving VitD or placebo.

Placebo

Participants will orally take a placebo (gelatin) capsule for the 6 days prior to their scheduled PDT visit. Participants in Arms 2 and 3 will be blinded to whether they are receiving VitD or placebo.

Photodynamic therapy (PDT)

PDT involves a topical photosensitizing agent called aminolevulinate (ALA) being applied to the tumor surface. ALA is then activated by shining a blue light on the skin, causing a photodynamic reaction to occur. Participants will receive PDT 1-14 days prior to their scheduled Mohs surgery or ED\&C visit.

Mohs surgery or electrodessication & curettage (ED&C) (standard of care)

Participants are eligible for this study by already planning to undergo Mohs surgery or ED\&C, which will be conducted per standard of care. For Arms 2 and 3, participants will undergo Mohs surgery or ED\&C 1-14 days after their PDT visit. For Arm 1, participants will undergo Mohs surgery or ED\&C at their scheduled time. All participants donate their discarded tissue from the Mohs surgery for research.

Primary outcome measure

  • Expression of immune checkpoint molecules [ Time Frame: At time of Mohs surgery or ED&C, up to Day 20 ]

Central Contacts and Locations

Central contacts

Edward Maytin, MD, PhD

(216) 346-6022maytine@ccf.org

Locations

Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute

Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator:

Edward Maytin, MD, PhD

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Mohs surgery
  • Electrodessication & curettage
  • ED&C
  • Photodynamic therapy
  • PDT
  • Vitamin D

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-08-18.