Vitamin D Supplementation as a Neoadjuvant for Photodynamic Therapy of Actinic Keratoses
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Photodynamic therapy (PDT); Vitamin D3
Intervention description: PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells
Noninvasive fluorescence dosimetry may be performed on up to 6 lesions. Levulan Kerastick will be applied to each lesion and left to incubate for 30 minutes. Blue light (Blu-U device, 20 J/cm2, 33 minutes) will be administered.; D3 pills (10,000 IU each) to be taken daily at home, beginning at either day -5 or day -14, as per their assignment
Participants will receive a 5-day or 14-day supplementation of Vitamin D10,000 IU depending on their baseline Vitamin D 25 Hydroxy result
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Study group will be compared to a baseline cohort of patients from a previous study (IRB 16-1615) who received the same regimen of PDT, but without any Vit D
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is open to individuals with Actinic Keratoses (skin lesions that have the
      potential to turn into skin cancer), who are receiving photodynamic therapy (PDT) as part of
      their clinical care. The purpose of this study is to test and demonstrate that vitamin D
      pre-treatment can enhance PDT efficacy in the treatment of Actinic Keratoses.

      Participants will be asked to take vitamin D supplements prior to their standard of care PDT
      treatment.

      Participation in the research will last about 3-4 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Actinic keratoses in sufficient numbers (>10) to warrant PDT therapy in the clinic

          -  Able to understand and willing to sign a written informed consent document

          -  Female subjects must not become pregnant during the study:

               -  The effects of 5-aminolevulinic acid (LevulanTM) on the human fetus are unknown.
                  For this reason, women of child-bearing potential must agree to use contraception
                  (double barrier method of birth control or abstinence) prior to study entry, and
                  throughout study participation. Should a woman become pregnant or suspect that
                  she is pregnant while she is participating in this study, she should inform the
                  treating physician immediately.

        Exclusion Criteria:

          -  Pregnant or nursing.

          -  At risk for hypercalcemia (renal disease, sarcoidosis, etc.)

          -  Using topical retinoids, since these can exacerbate the post-PDT erythema reaction.

          -  Using any topical treatment on their AKs; must stop at least one month prior.

          -  Currently undergoing treatment for other cancers with medical or radiation therapy.

          -  Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of
             the study material.

          -  Patients with history of a photosensitivity disease, such as porphyria cutanea tarda.

          -  Currently participating in another clinical trial.