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临床试验/NCT03832010
NCT03832010已完成4 期

Proof of Concept Investigation of the Steroid-reducing Effects of Crisaborole in Children

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年12月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
24
试验地点
1
主要终点
Steroid Usage Quantity

研究概览

简要总结

Atopic dermatitis, or eczema, is a chronic skin condition affecting many children. Crisaborole is a non-steroid topical medication which is FDA approved for children aged 2 and older for eczema. This research study seeks to investigate whether crisaborole reduces topical steroid use in children with atopic dermatitis.

详细描述

Atopic dermatitis (AD) is a chronic skin disease and a common affliction among children. Twice daily topical corticosteroid (TCS) use over several weeks is recommended for active inflammatory disease. Side effects of TCS range from cutaneous atrophy to hypothalamic-pituitary-adrenal axis suppression. Steroid phobia and misunderstanding often lead to poor compliance and inadequate disease control. Topical calcineurin inhibitors (TCIs) are currently recommended as steroid-reducing agents, especially on sensitive areas such as the face and skin folds. However, TCis are associated with burning reactions and come with black box warnings.

Crisaborole (Eucrisa), the newest topical prescription option for AD, is a phosphodiesterase-4 inhibitor with demonstrated efficacy in patients aged 2 and older with mild to moderate AD. Given the good tolerability and favorable safety profile, crisaborole makes for an alternative topical option to its predecessors. However, corresponding data are lacking. It would be of great interest to patients, patients' families and providers if crisaborole can be shown to reduce the amount of TCS necessary for control of AD. The investigators therefore propose a proof-of-concept study to investigate whether crisaborole can serve as an effective steroid-reducing agent.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
2 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Crisaborole

Active Comparator

Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema.

干预措施: Crisaborole (Drug)

Crisaborole

Active Comparator

Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema.

干预措施: Hydrocortisone Ointment (Drug)

Crisaborole

Active Comparator

Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema.

干预措施: Triamcinolone ointment (Drug)

Crisaborole

Active Comparator

Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema.

干预措施: Aquaphor (Drug)

Vehicle

Placebo Comparator

Participants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema.

干预措施: Hydrocortisone Ointment (Drug)

Vehicle

Placebo Comparator

Participants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema.

干预措施: Triamcinolone ointment (Drug)

Vehicle

Placebo Comparator

Participants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema.

干预措施: Aquaphor (Drug)

Control

Sham Comparator

Participants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema.

干预措施: Hydrocortisone Ointment (Drug)

Control

Sham Comparator

Participants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema.

干预措施: Triamcinolone ointment (Drug)

Control

Sham Comparator

Participants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema.

干预措施: Aquaphor (Drug)

结局指标

主要结局

Steroid Usage Quantity

时间窗: Day 90

Steroid usage measured in medication weight (grams)

Steroid Usage Frequency

时间窗: Day 90

Steroid usage measured in diary entries. Weekly average frequency of steroid use is reported.

次要结局

  • Severity of Itching as Assessed by Pruritus Score(Day 90)
  • Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index(Day 90)
  • Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire(Day 90)
  • Eczema Severity as Assessed by SCORing Atopic Dermatitis (SCORAD) Score(Day 0)
  • Eczema Severity Assessed by SCORAD Score(Day 90)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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