Pimecrolimus 1% Cream vs. Betamethasone Valerate 0.1% Cream in the Treatment of Facial Discoid Lupus Erythematosus: a Double-Blind Randomized, Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Efficacy end points included a combined score based on evaluation of erythema, infiltration and squamation
研究概览
简要总结
Discoid lupus erythematosus lesions are commonly treated with corticosteroids, but corticosteroids may induce side effects such as thinning of the skin or scarring. Therefore, an alternative medication with the same efficacy, but without the side-effects is sought after.
Pimecrolimus is a newer drug specially designed to treat inflammatory diseases of skin. Its efficacy in treating discoid lupus erythematosus has not been studied extensively yet. However studies performed till now show promising results. Long-term topical use of this medication has not shown any serious side-effects in other skin diseases.
In this study we aimed at comparing pimecrolimus efficacy with that of a common therapeutic choice, betamethasone valerate 0.1% cream, to see if pimecrolimus can be used as an alternative medication in treating discoid lupus erythematosus.
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, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients harboring discoid lupus erythematosus lesions on their face or neck
排除标准
- •Patients with discoid lupus erythematosus in the setting of systemic lupus erythematosus
- •Patients having a more disseminated disease
研究组 & 干预措施
1
Patients in arm one used twice daily pimecrolimus 1% cream on their facial discoid lupus erythematosus lesions for 8 weeks.
干预措施: Pimecrolimus 1% cream (Drug)
2
Twice daily betamethasone valerate 0.1% cream to facial lesions of discoid lupus erythematosus for 8 weeks
干预措施: betamethasone valerate 0.1% cream (Drug)
结局指标
主要结局
Efficacy end points included a combined score based on evaluation of erythema, infiltration and squamation
时间窗: 1st day, after 2, 4, 6 and 8 weeks of treatment
次要结局
- Secondary outcome: Safety assessments included monitoring of adverse events(1st day, after 2, 4, 6 and 8 weeks of treatment)