Clinical trial · Interventional
Vitamin D Supplementation as a Neoadjuvant for Photodynamic Therapy of Actinic Keratoses
NCT04140292CI-TRIAL-00059299completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photodynamic therapy (PDT) | Drug | — | UNRESOLVED |
| Vitamin D3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vitamin D3 + Photodynamic therapy (PDT)
- description
- Patients receive Vitamin D3 10,000 IU daily for 5 or 14 days depending on VitD baseline level. They then undergo Photodynamic therapy (PDT) for treatment of actinic keratosis.
- interventionNames
- Drug: Photodynamic therapy (PDT)
- Drug: Vitamin D3
Primary outcomes (1)
- measure
- Clinical PDT Response as Measured by Percent Change in AK Lesions From Baseline to 3 Months
- timeFrame
- 3 months after treatment
- description
- Clinical PDT response as measured by the percent change of AK lesions 3 months after treatment Baseline vitamin D (calcidiol) level will be taken for each patient.
Secondary outcomes (4)
- measure
- Correlation Between Vitamin D Receptor (VDR) Polymorphisms and Percent Reduction in AK
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBullock TA, Negrey J, Hu B, Warren CB, Hasan T, Maytin EV. Significant improvement of facial actinic keratoses after blue light photodynamic therapy with oral vitamin D pretreatment: An interventional cohort-controlled trial. J Am Acad Dermatol. 2022 Jul;87(1):80-86. doi: 10.1016/j.jaad.2022.02.067. Epub 2022 Mar 18. PMID 35314199