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临床试验/NCT06565117
NCT06565117已完成不适用

Efficacy of Dipotassium Glycyrrhizinate Emollients in the Maintenance Treatment of Adult Atopic Dermatitis: A Single-Center Randomized Controlled Study

The Affiliated Hospital of Xuzhou Medical University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
NRS

研究概览

简要总结

To investigate whether emollients containing dipotassium glycyrrhizinate have a sustained improvement in the clinical severity of mild to moderate atopic dermatitis in adult.

详细描述

Atopic dermatitis (atopic eczema, AD) is a common skin inflammatory disease, dry skin and itchy skin is a significant symptom of most AD, often accompany patients for life, seriously affecting the physical and mental health and work life of patients. The number of AD patients is increasing worldwide, while the prevalence rate in China has increased more significantly in the past 10 years. It is characterized by persistent skin dryness and a reduced function of the skin as a barrier to the external environment. Encourage the free use of moisturizers (emollients) as a baseline treatment for AD and add anti-inflammatory therapy as needed. Currently, topical corticosteroids are still the first-line treatment options. However, studies have confirmed that patients with AD are cautious about the use of topical corticosteroids. Maintaining the humidity of the skin and restoring the barrier function of the skin is the basis of the treatment of atopic dermatitis. And studies have shown that regular use of emollients can improve skin hydration, restore the skin barrier, reduce the frequency of attacks, and reduce the use of topical corticosteroids. In patients with AD, daily use of moisturizing emollients enhances the response to topical corticosteroid therapy, reduce percutaneous water loss (TEWL), restore the skin barrier and promote hydration, and can prevent or reduce AD attacks by improving the associated skin barrier defects, prolonging the time between AD episodes. The purpose of this study is to see whether emollients have sustained improvement on the clinical severity of adult atopic dermatitis in maintenance phase.

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
Single (Participant)

入排标准

年龄范围
17 Years 至 64 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Meet the Williams diagnostic criteria
  • SCORAD scores < 50 points, classified according to the severity levels of SCORAD scores, where scores of 0-25 are categorized as mild, and scores of 26-50 are categorized as moderate
  • No gender limit, age between 18-65 years old.

排除标准

  • Acute disease with erosion, exudation, secondary infection
  • There are currently other active inflammatory skin diseases
  • Antihistamine was used within 2 weeks prior to enrollment
  • Patients treated with emollients and receiving topical drugs (such as glucocorticoids and calcineurin inhibitors) within 1 week before enrollment
  • Patients have used phototherapy, systemic corticosteroids, immunosuppressants (such as cyclosporine, azathioprine, or immunoglobulin, etc.) within 4 weeks before enrollment
  • The systematic withdrawal time of biological agents or JAK inhibitor (dupilumab, omalizumab, et al) was less than 12 weeks
  • Malignant tumors, chronic systemic diseases (such as diabetes mellitus, hypothyroidism), or other acute and chronic infections
  • Those known to be allergic to the ingredients of emollient or Hydrocortisone cream
  • Patients who have attended or are attending other clinical investigators within three months
  • Patients judged unsuitable by the investigator to participate in this study.

研究组 & 干预措施

A:Emollient for systemic application

Experimental

Emollient for systemic application

干预措施: White yu green skin lotion (Drug)

B:Emollient was applied locally

Experimental

Apply skin lotion in locally affected skin areas or in areas previously affected by AD

干预措施: White yu green skin lotion (Drug)

结局指标

主要结局

NRS

时间窗: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks

Pain digital score

ADCT

时间窗: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks

Long-term disease control

SCORAD

时间窗: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks

Objective severity of the clinical signs of atopic dermatitis

POEM

时间窗: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks

Patient-oriented eczema measurement scores

DLQI

时间窗: Before treatment, Treatment for 2 weeks, 4 weeks, and 8 weeks

Quality of life index in dermatology

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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