Efficacy and Safety of PR022 Topical Gel to Treat Mild-to-Moderate Atopic Dermatitis

Inclusion Criteria:

- Male or female subjects 18 to 65 years of age

- EASI score ≤ 21 at baseline

- Diagnosis of mild-to-moderate (grade 2 or 3) AD according to the ISGA scale at
Baseline

- BSA affected by AD: 5% to 20% at start of treatment

- Willing and able to apply study treatments as directed, comply with study
instructions, and commit to attending all visits

- Willing and able to provide informed consent

- Use of adequate birth control, if of reproductive potential and sexually active

Exclusion Criteria:

- Widespread AD requiring systemic therapy

- Use of any of the following treatments within the specified time periods prior to Day
1

- Topical medications (topical antibiotics, topical corticosteroids, topical
antifungals, topical antihistamines, topical retinoids, topical calcipotriene,
tacrolimus, pimecrolimus, or other topical drug products for treatment of AD) or
bleach bath within 2 weeks prior to Day 1

- Systemic agents (cyclosporine, systemic corticosteroids [oral and injectable;
intranasal and inhaled corticosteroids are allowed if use is kept constant during the
study], systemic antibiotics, immunomodulators or immunosuppressive therapies,
interferon, cytotoxic drugs [e.g., methotrexate, cyclophosphamide, azathioprine], oral
retinoids, systemic antifungals, tacrolimus) for the treatment of AD within 4 weeks
prior to Day 1

- Ultraviolet (UV) therapy or use of a tanning booth/parlor within 6 weeks prior to Day
1

- Biologic therapies within 12 weeks (or 5 half-lives) prior to Day 1

- Antihistamines within 5 days prior to Day 1 [stable regimens (consistent use ≥ 14 days
before Day 1) of oral H1 antihistamines for non-AD lesion treatment will be allowed]

- Active or potentially recurrent dermatologic condition other than AD that may confound
evaluation

- Congenital ichthyosis (note that subjects with ichthyosis vulgaris are permitted)

- Known allergy to any ingredients of the investigational product formulation

- Significant confounding conditions as assessed by Investigator

- Any condition that could interfere with any evaluation in the study

- Pregnancy or breast feeding

- Any reason which, in the opinion of the Investigator, interferes with the ability of
the subject to participate in or complete the trial