A randomised controlled trial comparing once daily versus itch-based multiple daily application of clobetasol propionate 0.05% cream in lichen simplex chronicus

All India Institute of Medical Sciences1 个研究点分布在 1 个国家目标入组 50 人开始时间: 2022年10月28日最近更新: 2022年10月28日

试验速览

阶段: 2/3 期
状态: 尚未招募
发起方: All India Institute of Medical Sciences
入组人数: 50
试验地点: 1
主要终点: Change in the grade of lichenification of the lesion and change in 5 D pruritus score

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Lichen simplex chronicus is a chronic pruritic condition characterised by areas of thickened skin caused by habitual itching, scratching and rubbing of the skin. The standard prescription consists of topical corticosteroids applied once or twice daily but response is usually slow and partial. However in clinical practice it was found that itch-based multiple times application of high potency topical steroids led to reduction in total duration of treatment and thus the total cumulative dose. An itch-based application breaks the itch-scratch cycle and also leads to habit reversal and thus resulting in much better clinical outcome.

研究设计

研究类型: Interventional
分配方式: Coin toss, Lottery, toss of dice, shuffling cards etc
盲法: Open Label

入排标准

年龄范围: 1.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•1.Patients with clinical diagnosis of lichen simplex chronicus 2.More than 18 years of age 3.Patients with well circumscribed lesions of lichen simplex chronicus.

排除标准

•1.Use of systemic medications for treatment of other diseases which may act on the lesion 2.Lichen simplex chronicus due to underlying systemic or dermatological diseases 3.Lichen simplex chronicus superimposed on any other skin lesions 4.Lichen simplex chronicus of the anogenital region 5.Patients who do not consent for study or follow up 6.Pregnant and lactating females.

结局指标

主要结局

Change in the grade of lichenification of the lesion and change in 5 D pruritus score

时间窗: At the end of 16 weeks

次要结局

To assess the change in ItchyQol in patients with lichen simplex chronicus who are applying clobetasol propionate cream 0.05% once daily versus itch-based multiple times daily application.(At the end of 16 weeks)
To assess the change in VAS in patients with lichen simplex chronicus who are applying clobetasol propionate cream 0.05% once daily versus itch-based multiple times daily application.(At the end of 16 weeks)
To assess the change in area of lesion in patients with lichen simplex chronicus who are applying clobetasol propionate cream 0.05% once daily versus itch-based multiple times daily application.(At the end of 16 weeks)
To assess the side effects of topical corticosteroids in patients with lichen simplex chronicus who are applying clobetasol propionate cream 0.05% once daily versus itch-based multiple times daily application.(At the end of 16 weeks)

研究者

发起方

All India Institute of Medical Sciences

申办方类型

Government medical college

研究点 (1)

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