Skin Effects of a Topical Amino Acid Moisturizing Cream and Desonide in Atopic Dermatitis

This is a double-blind, randomized study comparing the effects of an amino acid moisturizing
cream and desonide cream in reducing skin symptoms associated with AD/eczema in subjects
with mild to moderate atopic dermatitis/eczema. Atopic dermatitis (AD), also known as
Eczema, is a chronic inflammatory skin disease that most commonly affects infants and
children with a prevalence of 10-20% in children as compared to 1-3% in adults. Patients
with AD have dry, irritated skin and often experience severe pruritus. Treatment of AD
involves avoidance of triggers and infectious agents, cutaneous hydration, control of
pruritus, and anti-inflammatory agents. Topical calcineurin inhibitors and steroids are
commonly used prescription anti-inflammatory treatments. Unfortunately, there are potential
side effects of long-term topical glucocorticoid use including skin atrophy, development of
striae, perioral dermatitis, acne, and even hypothalamic-pituitary-adrenal axis suppression.
However, many moisturizers are available without a prescription to soothe skin and reduce
symptoms associated with AD/eczema via increased hydration, improved barrier function and
anti-irritancy effects. The study cream being compared to desonide is a cosmetic
moisturizing formulation that contains a cosmetic amino acid dipeptide (e.g., contains 2
amino acids). This study is being conducted to understand the benefits of the amino acid
dipeptide moisturizing cream versus dermatologist-prescribed desonide cream in reducing the
symptoms associated with AD/eczema in order to evaluate its potential use in the eczema care
market. For this study, approximately 60 males and females, 18 years of age and older, who
are in general good health, but diagnosed with mild to moderate AD/eczema, will be
recruited, screened, and fully consented, with the goal of enrolling up to 42 evaluable
subjects. The 42 Subjects (21 subjects per group) will be randomly and equally assigned to
either one of 2 treatment groups of amino acid moisturizing cream or desonide cream. Neither
study subjects nor study staff will be aware of the treatment assigned. The subjects will be
asked to participate for approximately 5 weeks, over 5 study visits: Screening/Baseline,
Weeks 1-3 (Treatment Period), Regression weeks 4 & 5. Each subject will receive one, 15
gram, blinded study cream at each treatment visit to apply twice daily at home for 3 weeks;
a 2-week regression phase of no study cream will follow the treatment phase. A predetermined
target lesion will be assessed at each time point via established clinical grading scales
including: Target lesion Atopic Dermatitis Severity Index (TADSI), Eczema Area Severity
Index (EASI), Static IGA of targeted lesion, Total IGA (PGA) and Body Surface Area
involvement. All grading will be completed by the principal or sub-investigators.
Photographs will also be taken at each time point to assess changes during the treatment and
regression phases. Other established scales will be utilized to collect patient perception
of skin effects such as: Patient-Oriented Eczema Measure (POEM), subjects' assessment of
pruritus (VAS); a self-assessment questionnaire will be utilized to collect information on
perceived benefits and product aesthetics. This study has been IRB approved and is scheduled
to begin November of 2014 at Massachusetts General Hospital, specifically at the Clinical
Unit for Research Trials in Skin (CURTIS) under principal investigator, Alexandra B.
Kimball, MD. The study is being sponsored by NeoStrata Company, Inc, Princeton, NJ.

Inclusion Criteria:

1. Male or female subjects in general good health 18 years of age or older

2. Diagnosis of atopic dermatitis will be made based on clinical criteria. Each patient
must have at least one eczematous target lesion with area ranging from 10-500 cm2 of
mild to moderate severity with a grade of at least 6 on the TADSI scale, plus
presence of itch

3. Body surface area affected by AD lesions: ≤ 5% at start of treatment

Exclusion Criteria:

1. Pregnancy or breastfeeding

2. Any condition or therapy that in the investigator's opinion may pose a risk to the
subject or that could interfere with any evaluation in the study

3. Widespread AD requiring systemic therapy

4. Diagnosis of allergic contact dermatitis

5. Known hypersensitivity to any of the constituents or excipients of the
investigational product

6. Diagnosed with immunocompromised status

7. Use of systemic AD therapy, e.g. systemic corticosteroids, cyclosporine A,
azathioprine, mycophenolate mofetil, or phototherapy in the past 1 month.

8. Use of phototherapy in the past 2 weeks

9. Use of any topical AD therapy such as corticosteroids or topical immunomodulators in
the past 2 weeks

10. Use of local anti-itch or medical device treatments, e.g. benadryl, atopiclair,
epiceram in the past 2 weeks

11. Use of topical moisturizers less than 24 hours in advance of the baseline visit on
eczema lesions

12. Participation in another clinical research study with an investigational drug within
4 weeks before randomization in this study