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

Stopped early · Not applicable

Conditions studied: Eczema

In brief

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.

Key facts

Study ID

NCT02404493

Run by

Johnson & Johnson Consumer Inc. (J&JCI)

People needed

23

Starts

2015-03-01

Expected to finish

2016-03-01

Last updated by the study team

2017-03-24

Who can join

Age: 1 and older, up to 4. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• TKL Research — Fair Lawn, New Jersey, United States

Full record on ClinicalTrials.gov

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