Comparative Study Between Topical Crisaborole 2% and Topical Fluticasone Propionate 0.05% in Treatment of Patients With Mild to Moderate Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage improvement in objective SCORAD from baseline to Week 6
研究概览
简要总结
This randomized, double-blind trial compared topical crisaborole 2% with topical fluticasone propionate 0.05% in children aged 1-12 years with mild to moderate atopic dermatitis. Forty patients were assigned to receive either crisaborole or fluticasone twice daily on affected areas for 6 weeks, with responders (>75% improvement in SCORAD) continuing the same treatment twice weekly for 12 weeks as maintenance. The study evaluated improvement in disease severity using SCORAD and ISGA, pruritus scores, disease-free survival, and local tolerability. Both treatments were effective and well tolerated; fluticasone produced faster short-term improvement, while crisaborole showed a trend toward fewer relapses and similar overall safety in this pediatric population.
详细描述
This single-center, randomized, double-blind, controlled study enrolled 40 children with mild to moderate atopic dermatitis, defined by Hanifin and Rajka criteria, ISGA 2-3, and objective SCORAD up to 40. Participants were randomized to topical crisaborole 2% or fluticasone propionate 0.05%, applied twice daily for 6 weeks, with eligible responders continuing twice-weekly maintenance for 12 weeks. Outcomes included percentage improvement in SCORAD at Week 6, changes in ISGA and pruritus, disease-free survival, and local adverse events such as burning or redness. Both regimens improved disease severity with acceptable safety; fluticasone had greater early SCORAD improvement, while crisaborole showed numerically higher disease-free survival and lower relapse rates during follow-up.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of either sex aged 1 to 12 years.
- •Clinical diagnosis of atopic dermatitis based on Hanifin and Rajka criteria.
- •Mild to moderate disease with objective SCORAD up to
- •Investigator's Static Global Assessment (ISGA) score of 2 (mild) or 3 (moderate) at baseline.
排除标准
- •Use of systemic corticosteroids, nonsteroidal systemic immunosuppressants (e.g., cyclosporine, methotrexate), or phototherapy within 4 weeks before baseline.
- •Use of topical corticosteroids, transdermal corticosteroids, topical antibiotics, or any medicated topical agent within 1 week before baseline.
- •Severe atopic dermatitis (objective SCORAD > 40).
- •Significant medical condition requiring systemic medication (e.g., cancer).
- •Current clinical diagnosis of bacterial skin infection (such as abscess or impetigo).
研究组 & 干预措施
Crisaborole 2% twice daily
Children with mild to moderate atopic dermatitis receive topical crisaborole 2% ointment applied in a thin layer to all affected areas twice daily for 6 weeks, then twice weekly for 12 weeks as maintenance in responders (>75% SCORAD improvement).
干预措施: Crisaborole 2% topical ointment (Drug)
Fluticasone propionate 0.05% twice daily
Children with mild to moderate atopic dermatitis receive topical fluticasone propionate 0.05% cream applied in a thin layer to all affected areas twice daily for 6 weeks, then twice weekly for 12 weeks as maintenance in responders (>75% SCORAD improvement).
干预措施: Fluticasone propionate 0.05% topical cream (Drug)
结局指标
主要结局
Percentage improvement in objective SCORAD from baseline to Week 6
时间窗: Baseline to Week 6 of treatment
Objective SCORAD is assessed at baseline and Week 6, and the percentage improvement is calculated as the change from baseline divided by the baseline score, expressed as a percentage, to compare treatment response between the two groups.
次要结局
- Change in Investigator's Static Global Assessment (ISGA)(Baseline to Week 6)
- Change in peak pruritus numerical rating scale(Baseline to Week 18)
- Disease-free survival (relapse-free rate)(Week 6 to Week 18)
研究者
Noura Abdelmoneim Mohammed Elseessy
Lecturer of Dermatology Department, Faculty of Medicine, Kafr Elsheikh University
Kafrelsheikh University