A Three-week, Double-blind, Randomized Study to Evaluate the Effect of Pimecrolimus Cream 1% on Cathelicidin Expression in the Skin of Subjects With Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cathelicidin mRNA Expression Levels in Adult Skin From Patients With AD
研究概览
简要总结
The purpose of this study is to determine the effect of topical pimecrolimus on the immune system by assessing the levels of antimicrobial peptides in the skin of patients with eczema. It is hypothesized that pimecrolimus applied topically will repair the body's immune system in patients with eczema by increasing antimicrobial peptides.
详细描述
Patients with atopic dermatitis (AD) have higher rates of skin infections from viruses and bacteria. They also have an impaired innate immune system. Antimicrobial peptides are a component of the innate immune system which are decreased in atopics. In vitro, pimecrolimus has demonstrated its ability to increase antimicrobial peptides. This study will examine the ability of pimecrolimus to increase antimicrobial peptides in vivo in AD patients. Thus, the study will yield a better understanding of the role of pimecrolimus in regulating the immune system in atopics.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years
- •Target lesion IGA ≥2
- •Target IGA=0 (for non-lesional site)
- •Male or female of any race and ethnicity
- •Chronic AD for more than one year duration
- •Subject of child-bearing potential must be willing to practice effective birth control during the study
- •Subject agrees to comply with study requirements and attend all required visits.
排除标准
- •Patients ≥ 18 years of age with only AD of the face
- •Women of childbearing potential not using the contraception method(s) specified in this study (abstinence, IUD, diaphragm, oral contraceptives)
- •Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- •Hypersensitivity to pimecrolimus cream or any excipient of the cream
- •Subject has a skin disorder in addition to dermatitis in the areas to be treated
- •Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
- •Pregnant or nursing females
- •Immunocompromised patient (e.g., lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome), or with a history of active or malignant disease (excluding non-melanoma skin cancer)
- •History of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
- •Patients known to be non-compliant with a medication regimen
- •Subjects with significant concurrent medical condition(s) at screening that in the view of the investigator prohibits participation in the study (e.g., severe concurrent allergic disease, condition associated with malignancy, and condition associated with immunosuppression)
- •Active viral or fungal skin infections at the target areas
- •Previous participation in this study
- •Ongoing participation in another investigational trial
- •Use of any oral or topical antibiotic during the study and up to one week prior to entering the study
- •Use of any local therapy for AD less than one week prior to screening
- •Use of any systemic immunosuppressive therapy for AD less than four weeks prior to screening.
研究组 & 干预措施
Pimecrolimus
干预措施: Pimecrolimus (Drug)
Vehicle cream
干预措施: Vehicle cream (Other)
结局指标
主要结局
Cathelicidin mRNA Expression Levels in Adult Skin From Patients With AD
时间窗: 3 weeks
Delta-delta CT values were measured using RT-PCR of cathelicidin mRNA in human biopsy samples at baseline, and then 3 weeks after treatment with either pimecrolimus or placebo
次要结局
未报告次要终点
研究者
Richard Gallo
Chair
University of California, San Diego