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



Status:Terminated
Conditions:Skin and Soft Tissue Infections
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:Any
Updated:6/2/2016
Start Date:March 2015
End Date:February 2016

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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

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.

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.

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
We found this trial at
1
site
Fair Lawn, New Jersey 07410
Phone: 201-587-0500
?
mi
from
Fair Lawn, NJ
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