A Multi-Center Clinical Trial to Evaluate the Efficacy of an Over-the-Counter Cream in the Management of Mild to Moderate Atopic Dermatitis in Infants and Toddlers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline
研究概览
简要总结
This study is for infants with mild to moderate dry and itchy skin. This study will involve going to the doctor for 6 visits over 2 weeks. All participants' skin will be examined by a dermatologist to determine if they have atopic dermatitis and have an active mild to moderate eczema wound. Participant's parents/guardians will be asked a few questions to determine if their child qualifies for the study.
Then all participants' caregivers will complete a questionnaire at the beginning of the study. The child's skin will be examined to rate the level of their eczema and a trained examiner will grade the looks and symptoms of their eczema. All parents or guardians will be instructed how to apply the test product and how to record usage on a diary card and then apply the test product. The test product will be applied at least 2 times per day or more as needed on all body areas, including the face affected throughout the study.
One digital picture will be taken of one eczema wound. Another digital picture will be taken of the area around this wound. These pictures will be taken on Day 0 (Baseline), Day 3, and Day 14.
Once product is applied the skin will be examined for any adverse events and all participants' caregivers will complete a questionnaire on study day 1, 3, 7 and 14.
详细描述
This is a multi-center, two-arm clinical trial in participants aged 2 - 35 months with mild to moderate Atopic Dermatitis (AD) as determined by the study physician. A sufficient number of participants will be enrolled in this study to yield 40 participants who complete the trial, 30 in the investigational product group and 10 in the active control group.
The investigational and control (EpiCeram®) products will be used topically. Participant caregivers will be instructed to gently massage the assigned product into the participant's skin. The treatments will be applied at least 2 times per day on all body areas, including areas of the body and face affected by AD. No product should be applied within 4 hours of a site visit. These treatments will be used in place of the participant's current moisturizers and/or emollients.
Diaries will be completed by the participants' caregivers each day, beginning upon initiation of therapy and continuing until trial completion/discontinuation, and will include information on product application and use of rescue medication.
All participants will visit the clinical site for assessments at baseline (Day 0) and on Days 1, 2, 3, 7 and 14. Clinical assessments include the Eczema Area and Severity index (EASI) and Investigator's Global Atopic Dermatitis Assessment (IGADA). Instrumental assessment of hydration will be done using a Corneometer (Courage & Khazaka, Germany). Caregivers will also complete a questionnaire to assess product experience. The final visit will occur on Day 14 or on the day of participant withdrawal from the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Known sensitivity to any investigational product ingredient;
- •Use of a therapeutic (over the counter or prescription) body wash that contains an active ingredient for eczema;
- •Participation in any clinical study within 30 days of Visit 1;
- •Relative, partner or staff of any clinical research site personnel;
- •Active infection of any type at the start of the study;
- •Severe AD as determined by the Rajka-Langeland Severity Index
- •AD requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids. If a participant requires any of these medications as rescue therapy during the study, the participant will be discontinued from the trial;
- •Requires any inhaled or intranasal corticosteroids;
- •Other medical condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
研究组 & 干预措施
EPI
干预措施: EpiCeram® Skin Barrier Emulsion (Device)
NEE
干预措施: Colloidal Oatmeal Cream (Drug)
结局指标
主要结局
Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline
时间窗: Baseline to Day 3
The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline
时间窗: Baseline to Day 3
The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.
次要结局
- Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline(Baseline to Day 7)
- Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline(Baseline to Day 1)
- Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline(Baseline to Day 14)
- Corneometer Measurement on Day 0 - Post-Treatment - Change From Baseline(Baseline to Post -Treatment on Day 0)
- Corneometer Measurement on Day 1 - Change From Baseline(Baseline to Day 1)
- Corneometer Measurement on Day 2 - Change From Baseline(Baseline to Day 2)
- Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline(Baseline to Day 1)
- Eczema Area and Severity Index (EASI) on Day 2 - Change From Baseline(Baseline to Day 2)
- Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 2 - Change From Baseline(Baseline to Day 2)
- Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft(0 Days - Pre-Treatment)
- Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth(0 Days - Post-Treatment)
- Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy(2 Days)
- Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft(14 Days)
- Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline(Baseline to Day 14)
- Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline(Baseline to Day 7)
- Corneometer Measurement on Day 3 - Change From Baseline(Baseline to Day 3)
- Corneometer Measurement on Day 7 - Change From Baseline(Baseline to Day 7)
- Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft(0 Days - Pre-Treatment)
- Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth(0 Days - Pre-Treatment)
- Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth(0 Days - Post-Treatment)
- Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy(0 Days - Post-Treatment)
- Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy(0 Days - Post-Treatment)
- Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth(1 Day)
- Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft(0 Days - Post-Treatment)
- Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth(0 Days - Post-Treatment)
- Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth(0 Days - Post-Treatment)
- Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft(1 Day)
- Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth(1 Day)
- Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft(3 Days)
- Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth(3 Days)
- Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy(7 Days)
- Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft(7 Days)
- Corneometer Measurement on Day 14 - Change From Baseline(Baseline to Day 14)
- Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy(0 Days - Pre-Treatment)
- Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth(0 Days - Pre-Treatment)
- Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy(0 Days - Pre-Treatment)
- Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly(0 Days - Post-Treatment)
- Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft(0 Days - Post-Treatment)
- Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly(0 Days - Post-Treatment)
- Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy(1 Day)
- Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy(1 Day)
- Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft(1 Day)
- Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth(2 Days)
- Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy(2 Days)
- Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth(2 Days)
- Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth(0 Days - Pre-Treatment)
- Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth(0 Days - Pre-Treatment)
- Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth(1 Day)
- Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth(1 Day)
- Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft(2 Days)
- Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth(2 Days)
- Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth(2 Days)
- Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft(2 Days)
- Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth(3 Days)
- Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy(3 Days)
- Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft(3 Days)
- Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth(7 Days)
- Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth(7 Days)
- Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth(7 Days)
- Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth(14 Days)
- Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth(3 Days)
- Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy(3 Days)
- Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth(3 Days)
- Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth(14 Days)
- Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth(14 Days)
- Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent.(14 Days)
- Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth(7 Days)
- Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy(7 Days)
- Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy(14 Days)
- Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy(14 Days)
- Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft(14 Days)
- Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft(7 Days)
- Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth(14 Days)