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临床试验/jRCTs041240111
jRCTs041240111进行中（未招募）不适用

An exploratory clinical trial to investigate the effect of Difamilast on skin barrier function in patients with atopic dermatitis

未提供0 个研究点目标入组 20 人开始时间: 2024年11月12日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
20
主要终点
TEWL
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

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
Single Arm Study
干预模型
Single Assignment
主要目的
Treatment Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
18age old over 至 65age old under（—）
性别
All

入选标准

  • •Patients with atopic dermatitis
  • •Patients who meet all of the following criteria will be included.
  • •Patients who have given written informed consent to participation in this research
  • •Patients who are aged 18 years or older and 65 years old or younger at the time of informed consent and able to make outpatient visits
  • •Patients diagnosed with atopic dermatitis according to the diagnostic criteria of the Japanese Dermatological Association
  • •Patients in whom the severity (Investigator's Global Assessment [IGA]) of systemic skin eruption is <= 3 at the start of screening and at the start of treatment
  • •Patients with a TEWL level of >= 10 g/h/m2 at the forearm flexor at the start of screening and at the start of administration
  • •Healthy adults
  • •Persons who meet all of the following criteria will be included.
  • •Persons who have given written informed consent to participation in this research
  • •Healthy persons (males and females) who are aged between 18 and 65 years (inclusive) at the time of informed consent
  • •Persons without a history of atopic dermatitis
  • •4.Persons who have not applied topical agents on the face

排除标准

  • •Patients with atopic dermatitis
  • •Patients who meet any of the following criteria will be excluded from the research.
  • •Patients complicated with an active infection that may affect this research at the start of treatment
  • •Patients in whom the severity (pEASI) of skin eruption is >= 9 points both on the assessment area and the face at the start of screening and at the start of treatment
  • •Patients who have an ulcer or an erosion clearly forming plaque on the assessment area and the face at the start of treatment
  • •Patients who have an injury or a complication on the assessment area or the face that may affect this research at the start of treatment
  • •Patients who were affected by herpes simplex type 1 (herpes labialis, facial herpes)
  • •Patients who have received a biological product, an oral JAK inhibitor, a systemic corticosteroid, or a systemic immunosuppressant within 26 weeks before the start of treatment
  • •Patients who have received phototherapy (UVB, narrow-band UVB, PUVA, etc.) within 4 weeks before the start of treatment
  • •Patients who have used a strongest or very strong topical steroid on the assessment area and the face within 14 days before the start of treatment according to the Japanese guidelines for atopic dermatitis
  • •Patients who have used difamilast ointment, delgocitinib ointment, tacrolimus ointment, a strong or weaker topical steroid, or a moisturizer on the assessment area and the face within 7 days before the start of treatment
  • •Patients with a serious complication in the brain, liver, kidney, heart, lung, digestive system, blood, endocrine system, metabolic system, psychiatric system, etc.
  • •Patients with other diseases considered to affect the safety or evaluation of subjects by the principal investigator or subinvestigator
  • •Persons who are pregnant or may possibly be pregnant and persons who are lactating
  • •Healthy adults
  • •Persons who meet any of the following criteria will be excluded from the research.
  • •Persons with a skin disease on the face
  • •Persons with a predisposing factor for atopic dermatitis such as pollinosis
  • •Patients with other diseases considered to affect the safety or evaluation of subjects by the principal investigator or subinvestigator

结局指标

主要结局

TEWL

时间窗: at the end of the research

Amounts of change in TEWL from the start of treatment in patients treated with difamilast

SCH (forearm flexor)

时间窗: at the end of the research

Amounts of change in SCH from the start of treatment in patients treated with difamilast

次要结局

  • TEWL and SCH (forearm flexor)(at the start of treatment, at Week 2 of treatment, at the end of the research)
  • Skin eruption assessment(at the start of treatment, at Week 2 of treatment, at the end of the research)
  • Sebum RNA

研究者

发起方
未提供

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