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临床试验/NCT02178215
NCT02178215已完成3 期

Effect of Holly Mangrove Shower Gel Containing Acanthus Ebracteatus Vahl. on Skin Barrier Function in Atopic Dermatitis Patients

Mahidol University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年7月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Improvement of skin barrier function

研究概览

简要总结

Atopic dermatitis is a chronic intermittent inflammatory skin disease. Currently, there are many cosmeceutical skin products in which their major action affects skin hydration and skin barrier function. In addition, there are some herbal medication remedies used for the treatment of skin diseases based on the knowledge of Thai traditional medicine. Patients with pruritic rash symptoms who attended the Center of Applied Thai Traditional Medicine, Siriraj Hospital, were prescribed the Holly Mangrove Shower Gel to use and on the follow-up appointment showed significant improvement. Nevertheless, the knowledge of using this herbal medication for treating pruritic skin rash so far has been categorized as folk wisdom and not been confirmed by any clinical-trial study on its efficacy and mechanism of action.

Research teams chose Holly Mangrove Shower Gel containing Acanthus ebracteatus Vahl to act as adjunctive for treating atopic dermatitis. Thus, for the purpose of studying the efficacy of Holly Mangrove Shower Gel containing Acanthus ebracteatus Vahl in improving the skin barrier function in atopic dermatitis.

详细描述

The investigators team research with patients by separate patients into 2 groups and compare among each other. In the first group use placebo, the other group use Holly Mangrove Shower Gel. To compare outcomes, the investigators will measure transepidermal water loss, stratum corneum hydration, skin pH, sebum and wrinkles after using studied gel.

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
Triple (Participant, Investigator, Outcomes Assessor)

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

  • •Age 18 years old or above
  • •Diagnosed as atopic dermatitis (Hanafin and Rajka criteria)
  • •No active dermatitis within 2 weeks

排除标准

  • •Pregnancy or lactation
  • •Any other skin diseases on forearms

研究组 & 干预措施

Placebo shower gel

Placebo Comparator

•Wash forearm by prepared placebo shower gel twice a day

干预措施: Placebo shower gel (Other)

Holly Mangrove Shower Gel

Active Comparator

•Wash forearm by Holly Mangrove Showver gel twice a day

干预措施: Holly Mangrove Shower Gel (Other)

结局指标

主要结局

Improvement of skin barrier function

时间窗: baseline, 2 week

•Measurement of bioengineering property of skin using Tewameter (transepidermal water loss), Corneometer (stratum corneum hydration), pH meter (skin pH), sebumeter (sebum), and visioscan (wrinkle)

次要结局

  • Reduction of severity of pruritus(baseline, 2 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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