Vitamin D Supplementation as a Neoadjuvant for Photodynamic Therapy of Actinic Keratoses
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Clinical PDT Response as Measured by Percent Change in AK Lesions From Baseline to 3 Months
研究概览
简要总结
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.
详细描述
The primary objective of this study is to determine whether acute supplementation (neoadjuvant Vitamin D3), adjusted according to baseline Vitamin D status, can improve the clinical PDT response relative to participants receiving PDT alone
The secondary objective of this study is to determine whether gene polymorphisms in VDR and CYP27B1 are predictive for the degree of responsiveness to Vitamin D as a neoadjuvant for PDT.
This study is a non-randomized interventional trial, in which the study group will be compared to a baseline cohort of patients from a previous study who received the same regimen of PDT, but without any Vit D. It is anticipated that 30 participants will be involved in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Vitamin D3 + Photodynamic therapy (PDT)
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.
干预措施: Photodynamic therapy (PDT) (Drug)
Vitamin D3 + Photodynamic therapy (PDT)
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.
干预措施: Vitamin D3 (Drug)
结局指标
主要结局
Clinical PDT Response as Measured by Percent Change in AK Lesions From Baseline to 3 Months
时间窗: 3 months after treatment
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.
次要结局
- Correlation Between Vitamin D Receptor (VDR) Polymorphisms and Percent Reduction in AK(3 months after treatment)
- Number of Participants Reporting 1 or Higher on the Pain Scale(During treatment (at the 5 min mark), and again immediately afterwards.)
- Tolerability as Measured by Participants' Symptom Score Sheets(1 week after treatment)
- Accumulation of Protoporphyrin IX (PpIX) Within AK(3 months after treatment)