Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Atopic Dermatitis

This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II
trial, comparing the effect of twice daily B244 application for 28 days vs vehicle
application on treatment of mild to moderate AD

At Screening and Baseline, all subjects must have atopic dermatitis, as defined by the
Hanifin and Rajka criteria, which involves a minimum of 10% and a maximum of 30% body surface
area, EASI score of 10 to 21 and pruritus visual analogue scale scores of ≥ 5 points on the
VAS scale (at least moderate).

The total duration of the study will be approximately 9 weeks. Participants will report for a
Screening visit and if all inclusion criteria are met, subjects will go through a two week
washout phase before reporting for a Baseline visit.

Subjects will come in for visits at Day 14 (Week 2), Day 28 (Week 4). A final visit will be
conducted at Day 42 (Week 6).

Efficacy will be assessed using Atopic Dermatitis Area and Severity Index (EASI) and Visual
Analog Scale (VAS).

Blood and urine samples will be collected for standard safety laboratory tests and effect of
the drug on inflammatory biomarkers. Participant's safety will be monitored throughout the
study.

Investigators plan to enroll approximately 130 total patients.

Randomization will be 1:1 so that equal number of patients will be treated in each Arm of the
study.

Inclusion Criteria:

- Male and female subjects ≥18 years of age

- In good general health as determined by a thorough medical history and physical
examination, and vital signs

- Clinical diagnosis of mild to moderate atopic dermatitis according to the criteria of
Hanifin and Rajka

- Mild to moderate Atopic Dermatitis area and severity index [EASI] 10-21

- A score of at least ≥ 5 points (moderate pruritus) on the VAS for pruritus

- A minimum of 10% and not more than 30% of the subjects' BSA affected by atopic
dermatitis (affected is defined by physical examination findings: erythema, edema,
scaling, lichenification, excoriation, with the excoriation serving as the physical
examination correlate of pruritus)

- An IGA score of 2-3

- Patient has a history of AD for ≥12 months

- Ability to read and understand English and to provide written informed consent and
authorization for protected health information disclosure

Exclusion Criteria:

- Pregnant and lactating women by urine pregnancy testing

- Subjects with any significant clinical abnormalities which may interfere with study
participation

- Any skin condition which may interfere with evaluation of AD

- Atopic dermatitis only on the head or scalp

- Subjects with Atopic dermatitis on the face

- Unstable or actively infected atopic dermatitis

- Patients suffering from pruritus from conditions other than AD

- Patients with chronic pruritus due to systemic disease

- Patients with conditions requiring inhaled steroids

- Have concurrent skin disease of such severity in the study area that it could
interfere with the study evaluation

- Have active skin infections on the treatment area

- Have received or planning to receive topical corticosteroids, topical coal tar,
topical sulfur, topical PDE-4 inhibitors, topical antihistamines, topical antiseptics
or antibiotics, topical antifungals, bleach baths, UVA or UVB phototherapy,
oral/IV/inhaled steroids, antibiotics/antiviral/antifungal agents, oral probiotics,
glucocorticoids treatment, calcineurin inhibitors, immunomodulating biologic agents,
systemic glucocorticoids, systemic immunosuppressive or immunomodulatory agents within
2 weeks of Baseline visit.

- Current or recent history (≤3 months of systemic use of Otrexup™, Rasuvo®, Rheumatrex®
and Trexall™ or its generic versions such as Methotrexate

- History of being seropositive for human immunodeficiency virus (HIV) at screening by
laboratory testing at Screening

- History of being positive for Hepatitis B virus surface antigen (HBsAg) or positive
Hepatitis C virus antibody (HCV Ab) at screening by laboratory testing at Screening

- History of renal disease

- Use of any investigational drugs within the previous 30 days prior to dosing or within
a period of less than five times the drug's half-life, whichever is longer

- Use of any biologic within a period of 5 times its half-life

- Use of vinegar or bleach baths within 2 weeks of starting the study