跳至主要内容
临床试验/CTRI/2021/06/034406
CTRI/2021/06/034406已完成不适用

A real-world study to evaluate the effectiveness of a moisturizing cream as an adjuvant in the treatment of Eczema.

Dr Reddys Laboratories Ltd1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年6月28日最近更新:
适应症

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
Instrumental evaluation for Skin Hydration and Trans epidermal water loss

研究概览

简要总结

Day 0

  • Explanation of the Study and procedures.
  • Collection of Informed consent
  • Selection of volunteers by Inclusion/ exclusion criteria.
  • Participants will be randomized into 2 groups based on their EASI scores - One group will get prescribed treatment with moisturizing cream and other group will get only prescribed treatment without any moisturizing cream.
  • Baseline EASI scores
  • Instrumental readings using MMSC and VapoMeter
  • Administration of  self-assessment questionnaire to evaluate itching and burning sensation.

Week 2 and Week 4

  • Same parameters as mentioned above were measured.
  • Products were retrieved from the participants.

Conclusion:

When compared to baseline, Venusia Max Cream used as an adjuvant along with standard

treatment significantly reduced the EASI score, significantly increased the skin hydration

measured by MMSC and significantly reduced the trans epidermal water loss measured by

VapoMeter. It also significantly showed reduction in 5D pruritus and burning sensation in

self-assessment score.

Clinical dryness self-assessment score has been done using a binary scale. There was no

change in dryness perception by the participants in both the groups after the treatment.

Also, Venusia Max Cream improved the skin hydration significantly on Eczematous skin of

patients and significantly reduced the 5D Pruritis score compared to the group where

Venusia Max Cream was not used as an adjuvant along with standard treatment.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • •Voluntary men and women with Atopic Dermatitis, Eruptive Eczema, Chronic Lichenified Eczema, Lichen Simplex Chronicus, Discoid Eczema, Allergic Eczema, with EASI scores 8 -21 or more.

排除标准

  • •Pregnant women by UPT, Lactating mothers Participants with dry skin.
  • •Localised psoriasis patients.

结局指标

主要结局

Instrumental evaluation for Skin Hydration and Trans epidermal water loss

时间窗: Day 0, Week 2, Week 4

Clinical evaluation

时间窗: Day 0, Week 2, Week 4

Self-Assessment (cutaneous dryness, Itching, Burning)

时间窗: Day 0, Week 2, Week 4

次要结局

未报告次要终点

研究者

申办方类型
Pharmaceutical industry-Global

研究点 (1)

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