Vitamin D Supplementation as a Neoadjuvant for Photodynamic Therapy of Actinic Keratoses

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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.