NCT02451579已完成不适用
A Randomized, Double-blind, Placebo-controlled, Prospective Clinical Trial Evaluating the Role of Systemic Antihistamine Therapy in the Reduction of Adverse Effects Associated With Topical 5-aminolevulinic Acid Photodynamic Therapy
Goldman, Butterwick, Fitzpatrick and Groff1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Localized Skin Response
研究概览
简要总结
A double-blind, placebo controlled study conducted at a single study site. Evaluating the role of systemic antihistamine therapy in the reduction of adverse effects associated with topical 5-aminolevulinic acid photodynamic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18
- •Subjects with 5-20 actinic keratosis of the face
- •Patients undergoing photodynamic therapy (PDT) to the face for AK with 5-aminolevulinic acid (ALA) activated by blue light.
- •Must be willing to give and sign a HIPPA form, photo consent and informed consent form.
- •Must be willing to comply with study dosing and complete the entire course of the study.
- •Female patients will be either of non-childbearing potential defined as:
- •Having no uterus
- •No menses for at least 12 months.
- •(WOCBP) women of childbearing potential must agree to use an effective method of birth control during the course of the study, such as:
- •Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
- •Intrauterine coil
- •Bilateral tubal ligation
- •Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
- •Abstinence (If practicing abstinence must agree to use barrier method described above (d) if becomes sexually active).
- •Vasectomized partner g. Negative urine pregnancy test results Baseline prior to study entry (if applicable)
排除标准
- •Presence of incompletely healed wound in treatment area
- •Presence of known or suspected BCC or SCC in treatment area
- •Previous PDT or treatment of the face with any topical cytotoxic or immunomodulatory agent for AKs within the past 6 months
- •Co-existing potentially confounding skin condition within treatment area (e.g. eczema, psoriasis, XP, rosacea) at investigator's discretion
- •Presence of tattoo and/or scar in the treatment area that in the investigators opinion would interfere with study assessments
- •Subjects with known photosensitivity or taking photosensitizing medications listed below:
- •Oral diabetes medicines
- •Griseofulvin
- •Thiazide diuretics
- •Sulfonylureas
- •Phenothiazines
- •Tetracycline's
- •St. John's Wort
- •Use of oral/topical retinoids within 1 month of Baseline
- •Subjects with a history of sensitivity to porphyrins
- •Subjects with recently excessive exposure of the treatment area to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study
- •Female subjects who are pregnant, nursing an infant or planning a pregnancy during the study [throughout the course of the study
- •Presence or evidence of any conditions that in the opinion of the investigator might impede the subject's ability to give consent or comply with protocol requirements.
- •Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study
- •History of non-compliance with clinical research protocols
- •Ablative laser resurfacing to on their face within 12 months
- •Non-ablative laser or light procedures to their face within the past 3 months
- •Microdermabrasion (light or medium skin peel) treatment on their face within the past 30 days
研究组 & 干预措施
Cetirizine Hydrochloride
Active Comparator
Prophylactic use of cetirizine hydrochloride prior to and after Topical 5-aminolevulinic Acid Photodynamic Therapy
干预措施: Antihistamine Cetirizine Hydrochloride (Drug)
Placebo
Placebo Comparator
Prophylactic use of placebo prior to and after Topical 5-aminolevulinic Acid Photodynamic Therapy
干预措施: Placebo (Other)
结局指标
主要结局
Localized Skin Response
时间窗: Up to day 180
Localized Skin Response consisting of erythema, edema, crusting, exudation, Vesiculation/Pustulation and erosion/ ulceration Investigator evaluated on a standardized scale
次要结局
未报告次要终点
研究者
研究点 (1)
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