JPRN-jRCTs031190047已完成未知
Proactive management with topical corticosteroids ointment in pediatric atopic dermatitis:Superiority to rank-down therapy(Anticipate study)
Ohtsuki Mamitaro0 个研究点目标入组 52 人开始时间: 2019年6月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 52
研究概览
简要总结
In pediatric patients with atopic dermatitis, we randomly assigned patients to proactive therapy group and rank-down therapy group after up to 2-week induction treatment and treat them with 4-week remission maintenance period. As a result, no statistically significant difference was found between the treatment groups regarding the relapse rate during the remission maintenance treatment period, which is the primary endpoint, and no significant difference was found between the treatment groups in the other ef
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 6age old 至 <= 15age old（—）
- 性别
- All
入选标准
- •Patients must meet the following inclusion criteria to be eligible for this study.
- •(1) Japanese patients diagnosed with atopic dermatitis, prior to informed consent, according to the Definition and diagnostic criteria for atopic dermatitis by the Japanese Dermatological Association
- •(2) Patients aged >= 6 and <= 15 years at the time of informed consent and who can be treated on an outpatient basis
- •(3) An Investigator Global Assessment (IGA) score of 3 or more
- •(4) Patients who have used a strong or very strong topical steroid
- •(5) Informed consent by patient (where possible) or legal representative
排除标准
- •Patients meeting any of the following criteria are not to be enrolled in the study.
- •(1) Patients with skin infections caused by bacteria, fungi, spirochetes or viruses and patients with ectoparasitic skin diseases (scabies, pubic lice, etc.).
- •(2)History of hypersensitivity to any components of the topical steroid and/or moisturizer to be used
- •(3) Patients with ulcers (except for Bechet's disease) and patients with deep burns or frostbite of second degree or higher.
- •(4) Patients complicated with an active infection in the area the study drug is to be applied.
- •(5) Patients complicated with Kaposi's varicelliform eruption, scabies, molluscum contagious, psoriasis, disorders (Netherton syndrome, etc.) presenting with ichthyosiform erythroderma, collagen disease (SLE and dermatomyositis), and skin disorder on the area study drug is to be applied to, which can affect evaluation.
- •(6) Patients who used the following drug within 28 days prior to Visit 1 (at the time of informed consent)
- •Systemic adrenocortical steroid (oral, injectable, suppository, and inhaled)
- •Topical steroid (strongest)
- •Systemic immunosuppressant
- •Live vaccine
- •(7) Patients who received phototherapy (UVB, Narrow-band UVB, PUVA , etc.) within 28 days prior to Visit 1 (at the time of informed consent)
- •(8) Patients who participated in another clinical trial (including clinical trial of medical device) or clinical research involving intervention within 12 weeks prior to Visit 1 (at the time of informed consent)
- •(9) Patients determined by the investigator to be unsuitable for the study.
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