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

Johnson & Johnson (J&J)

Status: Terminated

Conditions: Eczema

Treatments: Device: EpiCeram Skin Barrier Emulsion; Drug: 1% Colloidal Oatmeal Balm

Study type: Interventional

Funder types: Industry

Identifiers

NCT02404493

CO-141020101115-THCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 6 to 47 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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23 participants in 2 patient groups

EpiCeram Skin Barrier Emulsion

Active Comparator group

Description:

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

Treatment:

Device: EpiCeram Skin Barrier Emulsion

1% Colloidal Oatmeal Balm

Experimental group

Description:

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.

Treatment:

Drug: 1% Colloidal Oatmeal Balm