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

• Status: Terminated
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
• Treatments: Decanoic acid

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