A comparative, multicenter, prospective, randomized study to evaluate efficacy, safety and prevention of relapse with Elovera AD emollient vs plain emollient in mild to moderate atopic dermatitis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- 1. Percentage of patients who achieved resolution in 4 weeks IGA score of clear or almost
研究概览
简要总结
Atopic dermatitis (AD) is a common, chronic skin disorder that can significantly impact the quality of life of affected individuals as well as their families. It is currently estimated that 10–20% of children and 1–3% of adults in developed countries are affected by the disorder.
According to multiple guidelines including consensus by Indian experts, AAD guidelines and EADV guidelines and irrespective of grade of AD, moisturizers or emollients are crucial to the first line management and maintenance of atopic dermatitis.
Hence, we decided to conduct a study to evaluate the efficacy, safety and prevention of relapse with Elovera AD emollient vs plain emollient in mild to moderate atopic dermatitis (AD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 3.00 Month(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients from 3 months-75 yrs.
- •Patients who suffer from mild to moderate AD (IGA score of 2-3)
- •Patients willing to provide informed consent/parental consent/assent.
排除标准
- •Patients not deemed fit to be prescribed topical steroids
- •Patients unwilling to give informed consent.
结局指标
主要结局
1. Percentage of patients who achieved resolution in 4 weeks IGA score of clear or almost
时间窗: Weekly, Day0, Day14(±2), Day28(±2), | Every 2 weeks (telephonic) till 3 months or as and | when patient experiences relapse
clear and ≥2-point reduction from baseline.
时间窗: Weekly, Day0, Day14(±2), Day28(±2), | Every 2 weeks (telephonic) till 3 months or as and | when patient experiences relapse
2. Percentage of patients who suffered from relapse (Relapse is defined as recurrence of either of AD symptoms like erythema, edema, excoriation and lichenification except itching).
时间窗: Weekly, Day0, Day14(±2), Day28(±2), | Every 2 weeks (telephonic) till 3 months or as and | when patient experiences relapse
次要结局
- 1. Time to resolution(2. Time to relapse)