DRKS00028981已完成4 期
Prospective study on effects of abrocitinib treatment of moderate to severe atopic dermatitis on skin barrier function - Abroskib
niversitätsklinikum Schleswig-Holstein, Campus Kiel, Abteilung für Dermatologie, Allergologie und Venerologie0 个研究点目标入组 20 人开始时间: 2022年12月19日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- •2. Age = 18 years at time of study entry.
- •3. Diagnosis of chronic atopic dermatitis for at least 1 year prior to enrollment based on American Academy Criteria
- •4. Eczema Area and Severity Index (EASI) score =12 at baseline visit (Week 0)
- •5. Investigator Global Assessment (IGA) =3 at baseline visit (Week 0)
- •6. Subject is willing and able to comply with the protocol for the duration of the study
- •7. Subject receives abrocitinib by the treating dermatologist within routine care
排除标准
- •1. Subject is unable to provide written informed consent or comply with the protocol
- •2. Concurrent enrolment in another clinical trial where the subject is receiving an IMP or participation in another clinical trial with investigational product during the last 30 days before inclusion or 7 half-lives of previously used trial medication, whichever is longer.
- •3. Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, or psoriasis.
- •4. Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD.
- •5. Having used systemic immunosuppressive/immunomodulating therapy (e.g. systemic corticosteroids methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, JAK inhibitors) or tanning beds or phototherapy during any week within the 4 weeks or receipt of any marketed biologic therapy (e.g., dupilumab, tralokinumab) within 3 months or 5
- •half-lives, whichever is longer, prior to baseline
- •6. Treatment of selected marker skin areas (non-lesional skin at volar forearm and extensor forearm, lesional skin) with topical corticosteroid or topical calcineurin inhibitor 1 week prior to baseline visit and throughout the study.
- •7. Treatment of skin areas of examination with emollients 24 hours prior to baseline visit and throughout the study.
研究者
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