EUCTR2019-002643-23-GB进行中（未招募）1 期
Validation of a novel composite of skin biomarkers as a primary outcome measure for evaluating the safety of treatments for atopic dermatitis: a randomized controlled trial (phase 2) comparing the effects of crisaborole 2% ointment to betamethasone valerate 0.1% cream on skin structure and function in participants with atopic dermatitis. - Skin bioMARkers for atopic eczema Therapy evaluation
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 37
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Adult participants with AD defined according to the UK working party diagnostic criteria
- •2.Male or female aged 18-65 years old at baseline (Visit 1)
- •3.Participants understands the purpose, modalities and potential risk of the trial
- •4.Participants able to read and understand English
- •5.Participants willing to sign the informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 37
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Participants undergoing active drug treatment for AD (excludes the use of emollients) at baseline (Visit 1) and subject to any applicable washout period as defined by in section 8.8 ‘Prior and Concomitant Medication’
- •2.Participants with a known allergy/hypersensitivity to any of the excipients of the trial investigational medicinal products.
- •3.Participants with acne, suntan, birth marks, multiple nevi, tattoos, blemishes or dense body hair that obstruct the test areas.
- •4.Investigator assessment of eczema severity at the treatment (anatomical) sites is almost clear or greater (score =1) based on the Investigators static global assessment scale at screening and baseline.
- •5.Participants with a condition that in the opinion of the investigator contradicts participation in the study.
- •6.Pregnant female participants; breastfeeding female participants; and female participants of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
- •7.Use of any topical product on the test areas within 7 days prior to Baseline/Day 1, including cosmetic moisturizers and sunscreen. Use of moisturizers and/or sunscreen is permitted during the study to manage dry skin and sun exposure in areas surrounding but not on or overlapping the test areas.
- •8.Participants who have used a tanning bed within 28 days of baseline (visit 1).
- •9.Participants who have used any medication that could interfere with the trial aim prior to the start of the study (baseline/visit 1) treatment, and subject to the applicable washout period, as define in section 8.8 ‘Prior and Concomitant Medication’.
- •10.Participants currently participating in another interventional clinical trial.
- •11.Participants is incapable of giving fully informed consent.
- •12.Participants judged by the PI to be inappropriate for the trial.
研究者
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