KCT0007876已完成未知
Evaluation of the efficacy and safety of skin-microbiome-derived skin barrier-enhancing cosmetics in atopic dermatitis: a proof-of-concept trial
Korean Skin Research Center0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 13(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1)Male or female volunteers aged 12 to 70 years with a diagnosis of atopic dermatitis IGA = 2 or 3 at screening and prior to product use
- •2)Volunteers with mild to moderate atopic dermatitis IGA = 2 or 3 at screening and prior to product use
- •3)Volunteers who have applied a stable dose of moisturizer at least once daily for at least 7 consecutive days prior to study entry
- •4)Volunteers who have been fully informed about the study and have voluntarily completed and signed an informed consent form.
- •5)Volunteers who can be followed up for the duration of the study
排除标准
- •1)Treatment with immunosuppressive/immunomodulatory medications or phototherapy for atopic dermatitis within the last 4 weeks or volunteers who, in the opinion of the investigator, are likely to require such treatment(s) during the 4-week period.
- •2)Volunteers treated with topical corticosteroids or topical calcineurin inhibitors within the last 2 weeks
- •3)Volunteers who have been treated with a biologic agent (e.g., omalizumab, dupilumab, and infliximab) within the last 16 weeks
- •4)Volunteers who have started treatment for atopic dermatitis with a new moisturizer prescription during the screening period
- •5)Volunteers planning or using any prohibited treatment during the study period
- •6)Volunteers who have been treated with a live (attenuated) vaccine within the last 12 weeks
- •7)Volunteers requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within the last 2 weeks
- •8)Volunteers with an active chronic or acute infection
- •9)Volunteers with a serious skin infection or skin disease within the last 1 week that may interfere with the study evaluation
- •10)Volunteers with chronic urticaria or active pruritus due to allergens such as scabies or insect bites within the past 1 week
- •11)Applicants with a history of human immunodeficiency virus (HIV) infection or a positive HIV serologic test at screening
- •12)Applicants with a history of alcohol or drug abuse within 2 years
- •13)Applicants with acute or chronic hepatitis or known cirrhosis
- •14)Volunteers with a history of malignancy within 5 years
- •15)Volunteers with comorbid severe condition(s) as determined by the investigator
- •16)Volunteers with planned or anticipated significant surgery during this period
- •17)Volunteers who are employees or family members of the study
- •18)Female volunteers who are pregnant or lactating or who plan to become pregnant or lactate during the study
研究者
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