UCI 14-92 / HS#2015-1889: Phase IV Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percent Change in the Number of Actinic Keratoses
研究概览
简要总结
Photodynamic therapy is an effective treatment for actinic keratoses. In the United States topical aminolevulinic acid (ALA) is approved as a photosensitizing agent for this treatment, and it has traditionally been activated with the use of an in-office artificial light source. This clinical trial seeks to measure the safety and efficacy of using natural sunlight to activate the ALA.
详细描述
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Initial Visit:
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study inclusion criteria reviewed
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consent forms reviewed
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creation of facial map for actinic keratoses
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face cleansed with chlorhexidine soap
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light curettage of precancerous skin lesions
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application of topical aminolevulinic acid (ALA)
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application of sunscreen
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patient then spends 2 hours outdoors in a shaded area
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after treatment the patient is to remain indoors for 48 hours
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3 month follow up visit
- facial map of actinic keratoses used to document treatment response
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6 month follow up visit
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facial map of actinic keratoses used to document treatment response
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
- 是
入选标准
- •Clinical diagnosis of >10 actinic keratoses on head and neck
- •Age ≥ 18 years (Because no dosing or adverse event data are currently available on the use of topical aminolevulinic acid in patients <18 years of age, children are excluded from this study)
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Patients currently undergoing anti-neoplastic therapy including but not limited to the following:
- •Topical imiquimod
- •Topical 5-fluorouracil
- •Topical ingenol mebutate
- •Topical diclofenac
- •Topical retinoids
- •Oral acitretin
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid
- •Patients with a known photosensitivity disorder including but not limited to porphyria, lupus, polymorphous light eruption, or immunobullous disease.
- •Patients taking known photosensitizing medications including but not limited to griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines.
- •pregnancy
研究组 & 干预措施
Aminolevulinic Acid with daylight photodynamic therapy arm
This study has a single, open label treatment arm. Patients will have topical aminolevulinic acid applied to the actinic keratoses in the treatment area (face/scalp) and will spend 2 hours outdoors in the shade to activate the medication. The patient then follow up in clinic 3 months and 6 months after their treatment to have the number of actinic keratoses counted.
干预措施: Aminolevulinic Acid (Drug)
结局指标
主要结局
Percent Change in the Number of Actinic Keratoses
时间窗: 0 (baseline) and 6 months
Percent change in number of actinic keratoses at 6 months
次要结局
- Number of Participants With Adverse Events(2 days)
研究者
Christopher Zachary
Principal Investigator
University of California, Irvine