A Randomized Controlled Trial of Clobetasol Propionate 0.05% Cream Versus Hydrocortisone 1% Cream in Children With Alopecia Areata
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change in scalp surface area affected over time
研究概览
简要总结
The use of topical steroids in the treatment of alopecia areata in children is common practice. However, no particular potency of steroid is accepted as the standard treatment due to the paucity of high quality evidence in the dermatology literature to substantiate their use. Two randomized controlled trials exist assessing topical steroid efficacy in this disorder, both have methodological limitations. The question remains as to which topical steroid is safe and efficacious for use. We performed a double blinded controlled trial to assess the usefulness of a class 1 topical steroid (clobestasol proprionate 0.05%) compared with a class 7 topical steroid (hydrocortisone 1%) in children with alopecia areata.
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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2 to 16 years
- •New patients presenting to The Hospital for Sick Children
- •Clinical confirmation of alopecia areata
- •Hair loss between 10 -75%
排除标准
- •Skin or medical problems requiring use of oral steroids
- •Immunosuppressants or PUVA for 4 weeks prior to the study
- •Use of inhaled and or intranasal steroids for 14 days prior to trial
- •Topical medicaments for 7 days prior to the trial
研究组 & 干预措施
Hydrocortisone 1%
干预措施: Hydrocortisone 1% (Drug)
Clobetasol Propionate 0.05%
干预措施: Clobetasol Propionate 0.05% (Drug)
结局指标
主要结局
Change in scalp surface area affected over time
时间窗: 24 weeks
The change in scalp surface area affected will be compared between the two intervention groups from baseline to 6 weeks, 12 weeks, and 24 weeks.
次要结局
- Change in scalp surface area affected from baseline to end of study(24 weeks)
- Over 50% reduction in scalp surface area affected(24 weeks)
研究者
Patricia Parkin
Staff Paediatrician
The Hospital for Sick Children