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临床试验/NCT02941432
NCT02941432已完成不适用

Pilot Study of Effects and Tolerance of Black Tea Compress Treatment in Facial Eczema and Perioral Dermatitis

University of Luebeck1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
1
主要终点
Change in Facial Eczema Activity and Severity Index (patients with facial eczema)

研究概览

简要总结

Facial eczema and perioral dermatitis are clinical entities that develop exclusively in the face and present a special therapeutic challenge. Topical corticosteroids that are commonly applied to treat eczema/dermatitis at other body sites are best avoided in the face, as they may result in rapid atrophy of facial skin and in the long term rather aggravate facial dermatoses. Black tea compresses have been successfully used by German-speaking dermatologists to treat facial eczema/dermatitis for decades. The precise mechanism of action is unknown but is presumably based on astringent properties of tannins in the black tea and on the antiinflammatory action of a wet compress as such. This therapy is cheap, universally available and practically free of side-effects. Despite these perceived advantages the effects and tolerance of black tea compresses have not been formally studied to date. Therefore, the investigators plan to treat 25 patients with facial eczema/perioral dermatitis over a period of 6 days each within the current trial. The disease activity will be assessed before, during and after completion of treatment using several clinical scores. In addition, side-effects, if any, will be documented.

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

  • •clinical diagnosis of facial eczema or perioral dermatitis
  • •minimum age of 18 years
  • •patient is capable of granting informed consent
  • •patient is expected to comply with the trial treatment protocol
  • •for outpatients: close place of residence

排除标准

  • •initiation or increase of systemic immunosuppressive or antibiotic treatment necessary
  • •psychiatric disease or other factors making poor patient compliance probable
  • •participation in another clinical trial within the past 6 months

研究组 & 干预措施

Black tea

Other

Black tea compress treatment

干预措施: Black tea compress treatment (Other)

结局指标

主要结局

Change in Facial Eczema Activity and Severity Index (patients with facial eczema)

时间窗: days 0, 3 and 6

Change in Perioral Dermatitis Severity Score (patients with perioral dermatitis)

时间窗: days 0, 3 and 6

Change in Investigator´s Global Assessment Score (all patients)

时间窗: days 0, 3 and 6

Change in Patient´s Self-Assessment Score (all patients)

时间窗: days 0, 3 and 6

Change in Visual Analog Scale for pruritus in the face (patients with facial eczema)

时间窗: days 0, 3 and 6

Change in Visual Analog Scale for tension feeling in the face (patients with perioral dermatitis)

时间窗: days 0, 3 and 6

次要结局

  • Side-effects(days 3 and 6)

研究者

发起方
University of Luebeck
申办方类型
Other
责任方
Principal Investigator
主要研究者

Iakov Shimanovich, MD

Attending Dermatologist

University of Luebeck

研究点 (1)

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