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