An Open-Label, Single-Arm Study to Evaluate Efficacy and Safety of Test Product i.e. All Purpose Cream in Mixed Population with Mild To Moderate Eczema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.To assess effect of test product on adult subject’s affected skin by using Eczema Area and Severity Index (EASI).
研究概览
简要总结
This study is proposed to evaluate and establish the benefits of thetest product on mildness, gentleness and non-irritability on adult and baby skinand soothes the skin, also determine the experience faster relief from pain ofand keeps the skin moisturized, upon application relieving dryness, redness,oedema, urticarial and any other reactions. The proposed benefits are evaluatedby the pediatrics, subjective assessment questionnaire and instrumentalevaluation at Day 1, Day 2, Day 7 and Day 14.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
1.To assess effect of test product on adult subject’s affected skin by using Eczema Area and Severity Index (EASI).
时间窗: 1.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days). | 2.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days) | 3.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days) | 4.Time 30 min (±5 mins), 1 hour (±15 mins), 2 hours (±15 mins), 4 hours (±15 mins), 8 hours (±15 mins), 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days)
2.To assess effect of test product on baby’s affected skin by using Three-Item Severity (TIS).
时间窗: 1.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days). | 2.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days) | 3.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days) | 4.Time 30 min (±5 mins), 1 hour (±15 mins), 2 hours (±15 mins), 4 hours (±15 mins), 8 hours (±15 mins), 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days)
4.subjective self-assessment questionnaire
时间窗: 1.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days). | 2.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days) | 3.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days) | 4.Time 30 min (±5 mins), 1 hour (±15 mins), 2 hours (±15 mins), 4 hours (±15 mins), 8 hours (±15 mins), 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days)
3.To assess effect of test product on skin in terms of mildness, gentleness, non-irritability, skin erythema/ redness, dryness, itching, rashes, oedema, pruritus, urticaria
时间窗: 1.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days). | 2.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days) | 3.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days) | 4.Time 30 min (±5 mins), 1 hour (±15 mins), 2 hours (±15 mins), 4 hours (±15 mins), 8 hours (±15 mins), 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days)
次要结局
- 1.To assess effect of test product on adult subject’s/baby’s affected skin for erythema using Mexameter®MX 18(2.To evaluate the effect of test product on adult subject’s/baby’s affected skin pH using Skin pH meter)