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

At least 60 subjects will be enrolled to ensure 40 (10 adults and 30 babies) completed
subjects. The tolerability of this formulation will be monitored in a small group of ten
adult subjects with mild to moderate eczema prior to testing in babies. In Group A, adults
will be asked to give their informed consent and an evaluation of inclusion/exclusion
criteria will be performed at the site. After screening, all subjects will be asked not to
use any skin treatments until the next clinic visit. Subjects will use the investigational
product as indicated at least twice per day on the face - cheeks only, arms, legs and torso
for 14 days. For both adults and babies, only the baseline measurements are collected at
5-10 minutes after first application, but not at Day 1, Day 7 and Day 14 visits. Babies from
6 to 36 months of age with mild to moderate eczema, who meet the eligibility criteria, will
follow a similar testing directions in Group B of the study.

Inclusion Criteria:

1. Male or female of any race or ethnicity, 6 months to 36 months of age and/or 18 years
and above.

2. 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.

3. Diagnosed as having Eczema.

4. Willing to stop the use of any non- assigned moisturizers and/or creams for the
entire duration of the study.

5. 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.

6. Willing to avoid excessive (more than 30 minutes) sun exposure without the use of
their regular brand of sunscreen and protective clothing.

7. Willing to not enter/use hot tub or whirlpool bath for the duration of the study.

8. 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.

Exclusion Criteria:

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

2. Adults Females who are pregnant (self-reported) or breastfeeding.

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

4. Atopic Dermatitis requiring systemic, super-potent (Class I) or potent (Class II or
III) topical corticosteroids.

5. Requires greater than 2.0 mg/day inhaled or intranasal corticosteroids.

6. Subjects who exhibit clinically active bacterial, fungal, or viral skin infections or
those who are susceptible to cutaneous infections.

7. Subjects who are currently on phototherapy.