A Comparative evaluation of the efficacy and safety of 2% crisaborole versus 0.1% tacrolimus ointment for the topical treatment of mild to moderate atopic dermatitis
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To determine the efficacy of 2% crisaborole ointment for treating mild to moderate cases of AD to achieve a clear or near clear skin (ISGA score 0 or 1) at baseline and in 4 weeks.
研究概览
简要总结
· Atopic dermatitis (AD) has a high prevalence, approaching 25% in children and 10% in adults, depending on the country of residence.Most patients with AD have mild-to-moderate disease amenable to topical therapy.Treatment of patients with mild and even moderate AD is centered on topical therapies, including emollients, topical corticosteroids (TCSs), topical calcineurin inhibitors (TCIs), and a topical phosphodiesterase 4 (PDE4) inhibitors. Use of TCIs and TCSs for long-term disease control might be limited because of side effects, such as skin atrophy (TCSs), local tolerance issues (TCIs), and patient/physician’s reluctance stemming from black box warnings (TCIs).Despite a growing understanding of AD pathomechanisms. No novel topical drugs had been approved for AD in more than a decade until the recent approval of crisaborole. Crisaborole ointment 2% is a nonsteroidal PDE4 inhibitor for the treatment of mild-to-moderate AD. In 2 identically designed, 28-day, phase 3 clinical trials in patients 2 years of age or older with mild-to-moderate AD, crisaborole was well tolerated and superior to vehicle in reducing global disease severity and signs and symptoms of AD. The objective of this study was to determine the efficacy of 2% crisaborole ointment vesus 0.1% tacrolimus ointment for treating mild to moderate cases of AD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 16.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients to be aged 2 years or older of either sex They must have a clinical diagnosis of AD according to Hanifin and Rajka criteria They should have 5% or more treatable body surface area involvement, and a baseline Investigator’s Static Global Assessment (ISGA) score of mild (2) or moderate (3).
排除标准
- •active infections or use of topical steroids in last 14 days.
结局指标
主要结局
To determine the efficacy of 2% crisaborole ointment for treating mild to moderate cases of AD to achieve a clear or near clear skin (ISGA score 0 or 1) at baseline and in 4 weeks.
时间窗: At baseline and in 4 weeks
次要结局
- To determine the change in pruritus score with both the treatment groups and compare between them(4 weeks)
研究者
Disha Chakraborty
Calcutta National Medical College and Hospital
