Tolerance Evaluation of a Nighttime Moisturizing Balm on Babies and Adults With Eczema

Completed · Not applicable

Conditions studied: Atopic Dermatitis (AD)

In brief

The purpose of this 14-day, two phase clinical study is to test the tolerance of a new over-the-counter moisturizing balm on subjects with eczema.

Key facts

Study ID

NCT02357940

Run by

Johnson & Johnson Consumer Inc. (J&JCI)

People needed

41

Starts

2015-01-01

Expected to finish

2016-01-01

Last updated by the study team

2017-01-10

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female of any race or ethnicity, 6 months to 36 months of age and/or 18 years and above.
• Adult subjects only - Male or non-pregnant, non-lactating female agree to the contraceptive requirements (including female partners use of a highly effective form of birth control for 3 months.
• Diagnosed as having Eczema.
• Willing to stop the use of any non- assigned moisturizers and/or creams for the entire duration of the study.
• Willing to not introduce any new fragrances (e.g. cleansers, lotions, perfumes, etc.), or in the household environment (e.g. room fresheners, cleansing agents, laundry detergents, etc.) for the duration of the study.
• Willing to avoid excessive (more than 30 minutes) sun exposure without the use of their regular brand of sunscreen and protective clothing.
• Willing to not enter/use hot tub or whirlpool bath for the duration of the study.
• Willing to avoid the beach during the course of the study, and willing to document any activities at or in a swimming pool in the daily diary.

You may not qualify if…

• Use of a therapeutic (over the counter or prescription) body wash that contains an active ingredient for eczema.
• Adults Females who are pregnant (self-reported) or breastfeeding.
• Participation in any clinical study within 30 days of Visit 1.
• Atopic Dermatitis requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids.
• Requires greater than 2.0 mg/day inhaled or intranasal corticosteroids.
• Subjects who exhibit clinically active bacterial, fungal, or viral skin infections or those who are susceptible to cutaneous infections.
• Subjects who are currently on phototherapy.

Where it is running

• Hill-top Research, Inc — St. Petersburg, Florida, United States
• TKL Research Inc. — Fair Lawn, New Jersey, United States

Full record on ClinicalTrials.gov

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