A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin

This is a multi-center, two-arm clinical trial in participants aged 2 - 35 months with mild
to moderate Atopic Dermatitis (AD) as determined by the study physician. A sufficient number
of participants will be enrolled in this study to yield 40 participants who complete the
trial, 30 in the investigational product group and 10 in the active control group.

The investigational and control (EpiCeram®) products will be used topically. Participant
caregivers will be instructed to gently massage the assigned product into the participant's
skin. The treatments will be applied at least 2 times per day on all body areas, including
areas of the body and face affected by AD. No product should be applied within 4 hours of a
site visit. These treatments will be used in place of the participant's current moisturizers
and/or emollients.

Diaries will be completed by the participants' caregivers each day, beginning upon
initiation of therapy and continuing until trial completion/discontinuation, and will
include information on product application and use of rescue medication.

All participants will visit the clinical site for assessments at baseline (Day 0) and on
Days 1, 2, 3, 7 and 14. Clinical assessments include the Eczema Area and Severity index
(EASI) and Investigator's Global Atopic Dermatitis Assessment (IGADA). Instrumental
assessment of hydration will be done using a Corneometer (Courage & Khazaka, Germany).
Caregivers will also complete a questionnaire to assess product experience. The final visit
will occur on Day 14 or on the day of participant withdrawal from the trial.

Inclusion Criteria

1. Able to comprehend and follow the requirements of the study (including availability
on scheduled visit dates) based upon research site personnel's assessment;

2. Caregiver is able and willing to provide written informed consent for the participant
to participate in the trial;

3. Male or female of any race or ethnicity, 2 months to 35 months of age;

4. Diagnosed as having Atopic Dermatitis (AD) on the basis of the criteria defined by
Hanifin and Rajka

5. Rated as having mild to moderate AD (graded between 3.0 and 7.5 inclusive) as per
Rajka-Langeland severity index

6. Willing to stop all emollients, moisturizers and/or other skin barrier cream or
emulsion treatments for the AD condition during the test period. If using
corticosteroids (not Class I, II, or III) or immunomodulators at study entry, must be
on a stable dose for a minimum of 1 month;

7. Willing to undergo a washout period of 2 days before the trial initiation where no
use of moisturizers or emollients will be allowed; and

8. Willing and able to comply with scheduled visits, treatment plan, and other trial
procedures.

Exclusion Criteria:

1. Known sensitivity to any investigational product ingredient;

2. Use of a therapeutic (over the counter or prescription) body wash that contains an
active ingredient for eczema;

3. Participation in any clinical study within 30 days of Visit 1;

4. Relative, partner or staff of any clinical research site personnel;

5. Active infection of any type at the start of the study;

6. Severe AD as determined by the Rajka-Langeland Severity Index

7. AD requiring systemic, super-potent (Class I) or potent (Class II or III) topical
corticosteroids. If a participant requires any of these medications as rescue therapy
during the study, the participant will be discontinued from the trial;

8. Requires any inhaled or intranasal corticosteroids;

9. Other medical condition that may increase the risk associated with study
participation or investigational product administration or may interfere with the
interpretation of study results and, in the judgment of the investigator, would make
the participant inappropriate for entry into this study.