CTRI/2024/09/073414已完成不适用
A prospective, interventional, randomized, open label, comparative, three arm, parallel allocation, single centre clinical study to evaluate the effectiveness of Test Products (Cream and Lotion) as an adjuvant in the treatment of Atopic Dermatitis.
Dr. Reddys Laboratories Ltd.1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年9月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- To assess the effect of test product on eczema by Dermatologist.
研究概览
简要总结
This is a prospective, interventional, randomized, open label, comparative, three arm, parallel allocation, single centre clinical study to evaluate the effectiveness of Test Products (Cream and Lotion) as an adjuvant in the treatment of Atopic Dermatitis.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.
All eligible subjects will undergo dermatological and instrumental assessment. Subjective feedback will also be taken regarding the perception of the product and subjects satisfaction after product usage. Safety will be assessed throughout the study by monitoring adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Male OR non-pregnant and non-lactating female subjects with age of 18-55 years (both inclusive at the time of consent). 2) Subjects diagnosed with atopic dermatitis based on Atopic Dermatitis Severity Index (ADSI) score between
- •8 (Mild to Moderate Eczema). 3) Subjects with two independent lesions. 4) Subject must be willing and able to apply the test product as directed, comply with study instructions and commit to all subsequent visits for the duration of the study. 5) Subjects having good general health and free of any disease state or physical condition that might impair evaluation which in the Investigators opinion, exposes the participant to an unacceptable risk by study participation. 6) Female subjects of childbearing potential must have a negative urine pregnancy test performed at screening visit. 7) Subjects willing to follow all the acceptable forms of contraception as applicable. 8) Subjects who are willing to participate in the study and give voluntary written informed consent. 9) Subjects who are willing and able to follow the study protocol to participate in the study. 10) Subjects willing to not participate in any other clinical study during participation in the current study.
排除标准
- •Female subjects who are pregnant or breastfeeding or planning pregnancy during the study period.
- •Subjects with dry skin and chronic illness.
- •Subjects with psoriasis (psoriatic lesions).
- •Subjects with any clinically significant systemic disease.
- •Subjects having known allergy to active ingredient OR raw material of the test product.
- •Presence of any cutaneous condition on test site that could interfere with study.
- •Subject who has used an Investigational product in any form or participated in any clinical trial within 30 days prior to first application.
- •Any other condition which could warrant exclusion from the study, as per the investigators discretion.
结局指标
主要结局
To assess the effect of test product on eczema by Dermatologist.
时间窗: Day 01, Day 14 and Day 28
次要结局
- To assess the effect of test product on Skin Moisturization(Day 01 and Day 02)
- To assess the effect of test product on skin barrier function by measuring Transepidermal Water Loss (TEWL)(Day 01 and Day 02)
- Subject Satisfaction Questionnaire(Day 02, Day 14 and Day 28)
- Product Response Index (Perception about Product)(Day 28)
研究者
Dr Bhagirath Patel
Cliantha Research
研究点 (1)
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