Clinical trial NCT02404493: Test to Determine the Effectiveness of Moisturizing Balm Used on Babies With Dry, Itchy Skin
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Eczema
Keywords: Atopic Dermatitis
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2015-03-31
Enrollment: 23
Sex: ALL
Minimum age (years): 6
Maximum age (years): 47
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Use of a therapeutic (over-the-counter or prescription) body wash that contains an active ingredient for eczema
2. Participation in any clinical study within 30 days of Visit 1
3. Active infection of any type at the start of the study
4. Diagnosed as having severe eczema
5. Atopic Dermatitis requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids
6. Child wakes up 3 or more times during the night
7. Child is awake more than 60 minutes during the night
8. Child sleeps for less than a total of 9 hours (during the day or night)
9. Child requires greater than 2.0 mg per day of inhaled or intranasal corticosteroids

Primary outcomes:
measure: Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment
timeFrame: Day 0 - Pretreatment (Baseline) to Day 0 - immediately post treatment
measure: Change From Baseline in Mean Corneometer Measurement 12 Hours After Treatment
timeFrame: Day 0 - Pretreatment (Baseline) to 12 Hours After treatment
Secondary outcomes:
measure: Change From Baseline in Mean Corneometer Measurement 24 Hours After Treatment
timeFrame: Day 0 - Pretreatment (Baseline) to 24 Hours After treatment
measure: Change From Baseline in Mean Corneometer Measurement 3 Days After Treatment
timeFrame: Day 0 - Pretreatment (Baseline) to 3 Days After treatment
measure: Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment
timeFrame: Day 0 - Pretreatment (Baseline) to 7 Days After treatment
measure: Change From Baseline in Mean Corneometer Measurement 14 Days After Treatment
timeFrame: Day 0 - Pretreatment (Baseline) to 14 Days After treatment
measure: Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline
timeFrame: Day 0 - Pretreatment (Baseline) to Day 1
measure: Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline
timeFrame: Day 0 - Pretreatment (Baseline) to Day 3
measure: Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline
timeFrame: Day 0 - Pretreatment (Baseline) to Day 7
measure: Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline
timeFrame: Day 0 - Pretreatment (Baseline) to Day 14
measure: Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline
timeFrame: Day 0 - Pretreatment (Baseline) to Day 1
measure: Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline
timeFrame: Day 0 - Pretreatment (Baseline) to Day 3
measure: Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline
timeFrame: Day 0 - Pretreatment (Baseline) to Day 7
measure: Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline
timeFrame: Day 0 - Pretreatment (Baseline) to Day 14
measure: Dryness Scale Score on Day 1 - Change From Baseline
timeFrame: Day 0 - Pretreatment (Baseline) to Day 1
measure: Dryness Scale Score on Day 3 - Change From Baseline
timeFrame: Day 0 - Pretreatment (Baseline) to Day 3
measure: Dryness Scale Score on Day 7 - Change From Baseline
timeFrame: Day 0 - Pretreatment (Baseline) to Day 7
measure: Dryness Scale Score on Day 14 - Change From Baseline
timeFrame: Day 0 - Pretreatment (Baseline) to Day 14
measure: Caregiver's Itch Assessment on Day 3 - Change From Baseline
timeFrame: Day 0 - Pretreatment (Baseline) to Day 3
measure: Caregiver's Itch Assessment on Day 7 - Change From Baseline
timeFrame: Day 0 - Pretreatment (Baseline) to Day 7
measure: Caregiver's Itch Assessment on Day 14 - Change From Baseline
timeFrame: Day 0 - Pretreatment (Baseline) to Day 14
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role
timeFrame: 0 Days Pretreatment (Baseline)
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement
timeFrame: 0 Days Pretreatment (Baseline)
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time Child Usually Put to Bed
timeFrame: 0 Days Pretreatment (Baseline)
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime
timeFrame: 0 Days Pretreatment (Baseline)
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time for Child to Fall Asleep
timeFrame: 0 Days Pretreatment (Baseline)
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Times Child Awakes During the Night
timeFrame: 0 Days Pretreatment (Baseline)
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Awake During the Night
timeFrame: 0 Days Pretreatment (Baseline)
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Longest Time Child is Asleep During the Night
timeFrame: 0 Days Pretreatment (Baseline)
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child is Asleep During the Night
timeFrame: 0 Days Pretreatment (Baseline)
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Naps Child Takes During the Day
timeFrame: 0 Days Pretreatment (Baseline)
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Sleeps During the Day
timeFrame: 0 Days Pretreatment (Baseline)
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem
timeFrame: 0 Days Pretreatment (Baseline)
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role
timeFrame: 7 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement
timeFrame: 7 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time Child Usually Put to Bed
timeFrame: 7 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime
timeFrame: 7 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time for Child to Fall Asleep
timeFrame: 7 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Times Child Awakes During the Night
timeFrame: 7 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Awake During the Night
timeFrame: 7 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Longest Time Child is Asleep During the Night
timeFrame: 7 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child is Asleep During the Night
timeFrame: 7 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Naps Child Takes During the Day
timeFrame: 7 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Sleeps During the Day
timeFrame: 7 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem
timeFrame: 7 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role
timeFrame: 14 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement
timeFrame: 14 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time Child Usually Put to Bed
timeFrame: 14 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime
timeFrame: 14 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time for Child to Fall Asleep
timeFrame: 14 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Times Child Awakes During the Night
timeFrame: 14 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Awake During the Night
timeFrame: 14 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Longest Time Child is Asleep During the Night
timeFrame: 14 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child is Asleep During the Night
timeFrame: 14 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Naps Child Takes During the Day
timeFrame: 14 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Sleeps During the Day
timeFrame: 14 Days
measure: Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall
timeFrame: 0 Days - Pre-treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall
timeFrame: 0 Days - Pre-treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall
timeFrame: 0 Days - Pre-treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema
timeFrame: 0 Days - Pre-treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema
timeFrame: 0 Days - Pre-treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema
timeFrame: 0 Days - Pre-treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week
timeFrame: 0 Days - Pre-treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning
timeFrame: 0 Days - Pre-treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week
timeFrame: 0 Days - Pre-treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Sleep Caregiver Got Over Past Week
timeFrame: 0 Days - Pre-treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - Number of Times Caregiver Woke Up
timeFrame: 0 Days - Pre-treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Time Caregiver Awake
timeFrame: 0 Days - Pre-treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week
timeFrame: 0 Days - Pre-treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week
timeFrame: 0 Days - Pre-treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week
timeFrame: 0 Days - Pre-treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week
timeFrame: 0 Days - Pre-treatment
measure: Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall
timeFrame: 0 Days - Post-treatment
measure: Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall
timeFrame: 0 Days - Post-treatment
measure: Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall
timeFrame: 0 Days - Post-treatment
measure: Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema
timeFrame: 0 Days - Post-treatment
measure: Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema
timeFrame: 0 Days - Post-treatment
measure: Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema
timeFrame: 0 Days - Post-treatment
measure: Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall
timeFrame: 3 Days
measure: Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall
timeFrame: 3 Days
measure: Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall
timeFrame: 3 Days
measure: Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema
timeFrame: 3 Days
measure: Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema
timeFrame: 3 Days
measure: Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema
timeFrame: 3 Days
measure: Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - Amount of Sleep Caregiver Got Over Past Week
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - Number of Times Caregiver Woke Up
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - Amount of Time Caregiver Awake
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - Amount of Sleep Caregiver Got Over Past Week
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - Number of Times Caregiver Woke Up
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - Amount of Time Caregiver Awake
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - Recommend Product
timeFrame: 14 Days
Other outcomes:
Locations:
city: Fair Lawn
country: United States
facility: TKL Research
state: New Jersey
Study officials:
affiliation: Johnson & Johnson Consumer Inc. (J&JCI)
name: Amisha Parikh-Das, PhD
role: STUDY_DIRECTOR
affiliation: TKL Research, Inc.
name: Ethlynn Schorr, MD
role: PRINCIPAL_INVESTIGATOR
References: