Phase 2
N=75
Vitamin D Supplementation as a Neoadjuvant for Photodynamic Therapy of Actinic Keratoses
Actinic Keratosis
Bottom Line
View on ClinicalTrials.gov: NCT04140292 ↗Enrolled (actual)
75
Serious AEs
—
Results posted
Jun 2022
Primary outcome: Primary: Clinical PDT Response as Measured by Percent Change in AK Lesions From Baseline to 3 Months — 59.1; 72.5 Percent change of AK lesions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Photodynamic therapy (PDT) (Drug); Vitamin D3 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical PDT Response as Measured by Percent Change in AK Lesions From Baseline to 3 Months |
59.1; 72.5 | — |
| SECONDARY Correlation Between Vitamin D Receptor (VDR) Polymorphisms and Percent Reduction in AK |
— | — |
| SECONDARY Number of Participants Reporting 1 or Higher on the Pain Scale |
0; 0 | — |
| SECONDARY Tolerability as Measured by Participants' Symptom Score Sheets |
3.7; 3.7 | — |
| SECONDARY Accumulation of Protoporphyrin IX (PpIX) Within AK |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT04140292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.