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临床试验/NCT02404493
NCT02404493终止不适用

A Clinical Trial to Evaluate the Efficacy of an Investigational Nighttime Moisturizing Balm in the Management of Mild to Moderate Atopic Dermatitis in Infants and Toddlers

Johnson & Johnson Consumer Inc. (J&JCI)1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2015年3月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
发起方
入组人数
23
试验地点
1
主要终点
Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this 3 week study is to test the effectiveness of an over-the-counter (OTC) skin balm in infants and toddlers with mild to moderate dry, itchy skin.

详细描述

50 infants and toddlers will be enrolled in this study to yield 40 completed subjects, 30 babies in the active treatment group and 10 babies in the positive control group.

Infants and toddlers aged 6 to 47 months inclusive will receive either a prescription or non-marketed investigational product for the treatment of eczema. Caregivers will be asked to stop use of prescription eczema treatments one week before the start of the study and during the study. Caregivers will apply study product to babies as indicated for 14 days to affected areas.

Subject caregivers will record treatment use in a daily diary and complete questionnaires. A dermatologist will examine and score the babies eczema and symptoms. Skin moisture levels will also be tested.

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
6 Months 至 47 Months（Child）
性别
All
接受健康志愿者
否

入选标准

  • •Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates)
  • •Male or female of any race or ethnicity, 6 months to 47 months of age;
  • •Diagnosed as having eczema
  • •Willing to stop use of all non-assigned moisturizers and/or creams for the entire duration of the study
  • •Child must have bedtime/sleep issues due to their dry, itchy skin

排除标准

  • •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
  • •Active infection of any type at the start of the study
  • •Diagnosed as having severe eczema
  • •Atopic Dermatitis requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids
  • •Child wakes up 3 or more times during the night
  • •Child is awake more than 60 minutes during the night
  • •Child sleeps for less than a total of 9 hours (during the day or night)
  • •Child requires greater than 2.0 mg per day of inhaled or intranasal corticosteroids

研究组 & 干预措施

EpiCeram Skin Barrier Emulsion

Active Comparator

Marketed. Apply in a thin layer to the affected skin areas two times per day (or as needed) and massage gently into the skin.

干预措施: EpiCeram Skin Barrier Emulsion (Device)

1% Colloidal Oatmeal Balm

Experimental

Not Yet Marketed. Apply in a thin layer to the affected skin areas at least once at night or more if needed (anytime), and massage gently into the skin.

干预措施: 1% Colloidal Oatmeal Balm (Drug)

结局指标

主要结局

Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment

时间窗: Day 0 - Pretreatment (Baseline) to Day 0 - immediately post treatment

Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.

Change From Baseline in Mean Corneometer Measurement 12 Hours After Treatment

时间窗: Day 0 - Pretreatment (Baseline) to 12 Hours After treatment

Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.

次要结局

  • Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline(Day 0 - Pretreatment (Baseline) to Day 3)
  • Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline(Day 0 - Pretreatment (Baseline) to Day 7)
  • Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline(Day 0 - Pretreatment (Baseline) to Day 14)
  • Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline(Day 0 - Pretreatment (Baseline) to Day 1)
  • Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline(Day 0 - Pretreatment (Baseline) to Day 3)
  • Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline(Day 0 - Pretreatment (Baseline) to Day 7)
  • Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline(Day 0 - Pretreatment (Baseline) to Day 14)
  • Dryness Scale Score on Day 1 - Change From Baseline(Day 0 - Pretreatment (Baseline) to Day 1)
  • Dryness Scale Score on Day 3 - Change From Baseline(Day 0 - Pretreatment (Baseline) to Day 3)
  • Change From Baseline in Mean Corneometer Measurement 24 Hours After Treatment(Day 0 - Pretreatment (Baseline) to 24 Hours After treatment)
  • Change From Baseline in Mean Corneometer Measurement 3 Days After Treatment(Day 0 - Pretreatment (Baseline) to 3 Days After treatment)
  • Change From Baseline in Mean Corneometer Measurement 14 Days After Treatment(Day 0 - Pretreatment (Baseline) to 14 Days After treatment)
  • Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline(Day 0 - Pretreatment (Baseline) to Day 1)
  • Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment(Day 0 - Pretreatment (Baseline) to 7 Days After treatment)
  • Dryness Scale Score on Day 7 - Change From Baseline(Day 0 - Pretreatment (Baseline) to Day 7)
  • Dryness Scale Score on Day 14 - Change From Baseline(Day 0 - Pretreatment (Baseline) to Day 14)
  • Caregiver's Itch Assessment on Day 3 - Change From Baseline(Day 0 - Pretreatment (Baseline) to Day 3)
  • Caregiver's Itch Assessment on Day 7 - Change From Baseline(Day 0 - Pretreatment (Baseline) to Day 7)
  • Caregiver's Itch Assessment on Day 14 - Change From Baseline(Day 0 - Pretreatment (Baseline) to Day 14)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role(0 Days Pretreatment (Baseline))
  • Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement(0 Days Pretreatment (Baseline))
  • Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time Child Usually Put to Bed(0 Days Pretreatment (Baseline))
  • Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime(0 Days Pretreatment (Baseline))
  • Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time for Child to Fall Asleep(0 Days Pretreatment (Baseline))
  • Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Times Child Awakes During the Night(0 Days Pretreatment (Baseline))
  • Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Awake During the Night(0 Days Pretreatment (Baseline))
  • Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Longest Time Child is Asleep During the Night(0 Days Pretreatment (Baseline))
  • Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child is Asleep During the Night(0 Days Pretreatment (Baseline))
  • Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Naps Child Takes During the Day(0 Days Pretreatment (Baseline))
  • Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Sleeps During the Day(0 Days Pretreatment (Baseline))
  • Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem(0 Days Pretreatment (Baseline))
  • Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role(7 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement(7 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time Child Usually Put to Bed(7 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime(7 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time for Child to Fall Asleep(7 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Times Child Awakes During the Night(7 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Awake During the Night(7 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Longest Time Child is Asleep During the Night(7 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child is Asleep During the Night(7 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Naps Child Takes During the Day(7 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Sleeps During the Day(7 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem(7 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role(14 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement(14 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time Child Usually Put to Bed(14 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime(14 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time for Child to Fall Asleep(14 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Times Child Awakes During the Night(14 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Awake During the Night(14 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Longest Time Child is Asleep During the Night(14 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child is Asleep During the Night(14 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Naps Child Takes During the Day(14 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Sleeps During the Day(14 Days)
  • Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem(14 Days)
  • Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall(0 Days - Pre-treatment)
  • Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall(0 Days - Pre-treatment)
  • Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall(0 Days - Pre-treatment)
  • Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema(0 Days - Pre-treatment)
  • Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema(0 Days - Pre-treatment)
  • Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema(0 Days - Pre-treatment)
  • Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week(0 Days - Pre-treatment)
  • Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning(0 Days - Pre-treatment)
  • Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week(0 Days - Pre-treatment)
  • Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Sleep Caregiver Got Over Past Week(0 Days - Pre-treatment)
  • Caregiver Questionnaire on Day 0 Pre-treatment - Number of Times Caregiver Woke Up(0 Days - Pre-treatment)
  • Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Time Caregiver Awake(0 Days - Pre-treatment)
  • Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week(0 Days - Pre-treatment)
  • Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week(0 Days - Pre-treatment)
  • Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week(0 Days - Pre-treatment)
  • Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week(0 Days - Pre-treatment)
  • Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall(0 Days - Post-treatment)
  • Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall(0 Days - Post-treatment)
  • Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall(0 Days - Post-treatment)
  • Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall(3 Days)
  • Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema(0 Days - Post-treatment)
  • Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema(0 Days - Post-treatment)
  • Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema(0 Days - Post-treatment)
  • Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall(3 Days)
  • Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema(3 Days)
  • Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall(3 Days)
  • Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema(3 Days)
  • Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema(3 Days)
  • Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall(7 Days)
  • Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall(7 Days)
  • Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning(7 Days)
  • Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall(7 Days)
  • Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema(7 Days)
  • Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema(7 Days)
  • Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema(7 Days)
  • Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week(7 Days)
  • Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week(7 Days)
  • Caregiver Questionnaire on Day 7 - Amount of Sleep Caregiver Got Over Past Week(7 Days)
  • Caregiver Questionnaire on Day 7 - Number of Times Caregiver Woke Up(7 Days)
  • Caregiver Questionnaire on Day 7 - Amount of Time Caregiver Awake(7 Days)
  • Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week(7 Days)
  • Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week(7 Days)
  • Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week(7 Days)
  • Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week(7 Days)
  • Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall(14 Days)
  • Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall(14 Days)
  • Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall(14 Days)
  • Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema(14 Days)
  • Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema(14 Days)
  • Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema(14 Days)
  • Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week(14 Days)
  • Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning(14 Days)
  • Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week(14 Days)
  • Caregiver Questionnaire on Day 14 - Amount of Sleep Caregiver Got Over Past Week(14 Days)
  • Caregiver Questionnaire on Day 14 - Number of Times Caregiver Woke Up(14 Days)
  • Caregiver Questionnaire on Day 14 - Amount of Time Caregiver Awake(14 Days)
  • Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week(14 Days)
  • Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week(14 Days)
  • Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week(14 Days)
  • Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week(14 Days)
  • Caregiver Questionnaire on Day 14 - Recommend Product(14 Days)

研究者

发起方
Johnson & Johnson Consumer Inc. (J&JCI)
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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