Test to Determine the Effectiveness of Moisturizing Balm Used on Babies With Dry, Itchy Skin

Eczema Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02404493
• Other study ID #: CO-141020101115-THCT
• Status: Terminated
• Phase: N/A
• First received: March 18, 2015
• Last updated: May 31, 2016
• Start date: March 2015
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 47 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eczema

Intervention

Device:
• EpiCeram Skin Barrier Emulsion
EpiCeram Skin Barrier Emulsion

Drug:
• Experimental Product 1% Colloidal Oatmeal Balm
Experimental Product 1% Colloidal Oatmeal Balm

Locations

Country	Name	City	State
United States	TKL Research	Fair Lawn	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer Inc. (J&JCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Caregiver questionnaire data assessing product experience	Questions to be answered immediately PRE-treatment by participants' caregivers. Questions include overall look (smooth, healthy) and feel (soft, smooth) of participants' skin; and affected area's look (smooth, healthy) and feel (soft, smooth). Caregivers will choose from 6 answers: I Don't Have an Opinion, Strongly Agree, Somewhat Agree, Neither Agree or Disagree, Somewhat Disagree and Strongly Disagree.	Visit 2 (Day 0)	No
Other	Caregiver questionnaire data assessing product experience	Questions to be answered immediately POST-treatment by participants' caregivers. Questions include overall look (smooth, healthy) and feel (soft, smooth) of participants' skin; and affected area's look (smooth, healthy) and feel (soft, smooth). Caregivers will choose from 6 answers: I Don't Have an Opinion, Strongly Agree, Somewhat Agree, Neither Agree or Disagree, Somewhat Disagree and Strongly Disagree.	Visit 2 (Day 0)	No
Other	Caregiver questionnaire data assessing product experience	Questions to be answered immediately post -treatment by participants' caregivers. Questions include overall look (smooth, healthy) and feel (soft, smooth) of participants' skin; and affected area's look (smooth, healthy) and feel (soft, smooth). Caregivers will choose from 6 answers: I Don't Have an Opinion, Strongly Agree, Somewhat Agree, Neither Agree or Disagree, Somewhat Disagree and Strongly Disagree.	Visit 5 (Day 3)	No
Other	Caregiver questionnaire data assessing product experience	Questions to be answered immediately post -treatment by participants' caregivers. Questions include overall look (smooth, healthy) and feel (soft, smooth) of participants' skin; and affected area's look (smooth, healthy) and feel (soft, smooth). Caregivers will choose from 6 answers: I Don't Have an Opinion, Strongly Agree, Somewhat Agree, Neither Agree or Disagree, Somewhat Disagree and Strongly Disagree.	Visit 6 (Day 7)	No
Other	Caregiver questionnaire data assessing product experience	Questions to be answered immediately post -treatment by participants' caregivers. Questions include overall look (smooth, healthy) and feel (soft, smooth) of participants' skin; and affected area's look (smooth, healthy) and feel (soft, smooth). Caregivers will choose from 6 answers: I Don't Have an Opinion, Strongly Agree, Somewhat Agree, Neither Agree or Disagree, Somewhat Disagree and Strongly Disagree.	Visit 7 (Day 14)	No
Other	Caregiver itch assessment	• NEW Description: Question to be answered pre-treatment by participant's caregiver regarding how much participant has been itchy and scratching. Caregiver will choose from 5 answers: None, A Little, A Lot, All the Time and I Don't Have an Opinion.	Visit 2 (Day 0)	No
Other	Caregiver itch assessment	• NEW Description: Question to be answered pre-treatment by participant's caregiver regarding how much participant has been itchy and scratching. Caregiver will choose from 5 answers: None, A Little, A Lot, All the Time and I Don't Have an Opinion.	Visit 5 (Day 3)	No
Other	Caregiver itch assessment	• NEW Description: Question to be answered pre-treatment by participant's caregiver regarding how much participant has been itchy and scratching. Caregiver will choose from 5 answers: None, A Little, A Lot, All the Time and I Don't Have an Opinion.	Visit 6 (Day 7)	No
Other	Caregiver itch assessment	• NEW Description: Question to be answered pre-treatment by participant's caregiver regarding how much participant has been itchy and scratching. Caregiver will choose from 5 answers: None, A Little, A Lot, All the Time and I Don't Have an Opinion.	Visit 7 (Day 14)	No
Primary	Corneometer measurements	Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurements will be taken before and after product treatment.	Baseline Visit 2 (Day 0)	No
Primary	Corneometer measurements	Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurement will be taken at the beginning of the subject's visit.	Visit 3 (Day 1)	No
Secondary	EASI	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.	Baseline Visit 2 (Day 0)	No
Secondary	EASI	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.	Visit 4 (Day 1)	No
Secondary	EASI	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.	Visit 5 (Day 3)	No
Secondary	EASI	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.	Visit 6 (Day 7)	No
Secondary	EASI	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.	Visit 7 (Day 14)	No
Secondary	IGADA	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 where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number signs and symptoms, the final rating will be clear, almost clear, mild, moderate, severe or very severe.	Visit 2 (Day 0)	No
Secondary	IGADA	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 where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number signs and symptoms, the final rating will be clear, almost clear, mild, moderate, severe or very severe.	Visit 4 (Day 1)	No
Secondary	IGADA	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 where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number signs and symptoms, the final rating will be clear, almost clear, mild, moderate, severe or very severe.	Visit 5 (Day 3)	No
Secondary	IGADA	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 where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number signs and symptoms, the final rating will be clear, almost clear, mild, moderate, severe or very severe.	Visit 6 (Day 7)	No
Secondary	IGADA	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 where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number signs and symptoms, the final rating will be clear, almost clear, mild, moderate, severe or very severe.	Visit 7 (Day 14)	No
Secondary	Corneometer Measurements	Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurement will be taken during the subject's visit.	Visit 4 (Day 1)	No
Secondary	Corneometer Measurements	Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurement will be taken during the subject's visit.	Visit 5 (Day 3)	No
Secondary	Corneometer Measurements	Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurement will be taken during the subject's visit.	Visit 6 (Day 7)	No
Secondary	Corneometer Measurements	Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurement will be taken during the subject's visit.	Visit 7 (Day 14)	No
Secondary	BISQ	• NEW Description: The Brief Infant Sleep Questionnaire (BISQ) will ask parents about their child's sleeping location, night awakenings, methods of falling asleep and daily sleep schedule.	Visit 2 (Day 0)	No
Secondary	BISQ	• NEW Description: The Brief Infant Sleep Questionnaire (BISQ) will ask parents about their child's sleeping location, night awakenings, methods of falling asleep and daily sleep schedule.	Visit 6 (Day 7)	No
Secondary	BISQ	• NEW Description: The Brief Infant Sleep Questionnaire (BISQ) will ask parents about their child's sleeping location, night awakenings, methods of falling asleep and daily sleep schedule.	Visit 7 (Day 14)	No