JPRN-jRCTs031230314招募中Unknown
A Randomized Controlled Study of the Efficacy and Safety of Proactive Treatment with Delgocitinib Ointment in the Maintenance of Remission in Atopic Dermatitis
Fujisawa Takao0 个研究点目标入组 200 人开始时间: 2023年8月29日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 6month old 至 ot applicable（—）
- 性别
- All
入选标准
- •Induction phase of remission
- •1) Japanese patients diagnosed with atopic dermatitis by the time of consent based on the diagnostic criteria for atopic dermatitis (Hanifin & Rajka)
- •2) Patients who are at least 6 months of age at the time of consent and capable of making outpatient visits
- •3) Patients with a vIGA score of 2 (mild disease) or higher at Visit 1
- •4) Patients with a skin rash area that can be treated with 5 g of topical drug per dose (10 g per day) on Visit 1.
- •Remission Maintenance Phase
- •Patients with a vIGA score of 0 (no symptoms) or 1 (almost no symptoms) at the completion of induction of remission
排除标准
- •Induction phase of remission
- •Patients who violate the following criteria will be excluded from the investigation to be conducted during Visit 1.
- •1) Patients with active infection at the site where the investigational drug is to be administered during Visit 1
- •2) Patients with the following complications on Visit 1
- •Kaposi's varicella-like rash
- •Molluscum contagiosum
- •Impetigo contagiosa
- •Diseases presenting with ichthyosis erythroderma (Netherton's syndrome)
- •Collagen diseases (SLE and dermatomyositis)
- •Contact dermatitis
- •Skin diseases at the site where the investigational drug is to be applied that may affect the evaluation
- •3) Patients scheduled to start allergen immunotherapy or oral immunotherapy or those currently receiving these therapies scheduled to increase the dose
- •4) Patients who used the following drugs within 24 weeks prior to Visit 1
- •Biological agents (cytokine agents, antibody drugs, etc.)
- •5) Patients who used the following drugs within 28 days prior to Visit 1
- •Systemic corticosteroids (oral, injectable, suppository and inhalant)
- •Systemic immunosuppressive drugs (cyclosporine, methotrexate, oral JAK inhibitors, etc.)
- •6) Patients who received the following therapies within 28 days prior to Visit 1
- •Phototherapy (UVB, Narrow-band UVB, PUVA, etc.)
- •7) Patients with serious complications of the brain, liver, kidney, heart, lungs, digestive organs, blood, endocrine system, metabolic system, or mental system
- •8) Patients with a history of severe drug allergy such as anaphylactic shock
- •9) Patients with a history of drug or alcohol dependence
- •10) Patients who have participated in other research or clinical studies involving medical devices or interventions within 12 weeks prior to Visit 1
- •11) Patients with a history of adverse reactions to delgocitinib ointment
- •12) Other research subjects who are judged to be inappropriate as research subjects by the principal investigator or subinvestigator.
- •Remission maintenance phase
- •1) Research Subjects who discontinued during the induction phase of remission or who developed serious adverse events or illnesses
- •2) Other Research Subjects who are deemed inappropriate as Research Subjects by the Principal Investigator or the Attending Investigator
研究者
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