Study of Crisaborole Ointment 2% in Mild to Moderate Atopic Dermatitis
Study of Crisaborole Ointment 2% in Mild to Moderate Atopic Dermatitis
The purpose of this study is to document the timing of improvement in atopic dermatitis
 symptoms and severity following the application of crisaborole ointment 2% in patients 2
 years or older with mild to moderate atopic dermatitis. Crisaborole ointment 2% will be
 applied topically twice daily for four weeks and progress will be assessed by photography and
 patient-reports.
Inclusion Criteria:

 1. Subject is a male or female aged at least 2 years of age.

 2. Subject has confirmed clinical diagnosis of active atopic dermatitis (AD) according to
 the Hanifin and Rajka criteria.

 3. AD diagnosed at least 6 months prior to the screening visit and severity of disease
 has been stable for the past month.

 4. Subject has a BSA covered with atopic dermatitis of at least 1% (excluding face,
 scalp, genitals, groin area) [face, genitals and groin will not for be used photos]

 5. Subject has a global ISGA of mild (2) or moderate (3) at the baseline visit.

 6. Subject must be willing to avoid excessive exposure to natural or artificial
 ultraviolet radiation.

 7. Women of childbearing potential who are heterosexually active must practice a highly
 effective method of birth control such as an oral, injected or implanted hormonal
 methods of contraception, intrauterine device (IUD), spermicidal condom, male partner
 sterilization (the vasectomized partner should be the sole partner for that subject)
 or true abstinence. If a female subject's childbearing potential changes after start
 of the study (e.g., a woman who is not heterosexually active becomes active, a
 premenarchal woman experiences menarche), she must begin practicing a highly effective
 method of birth control, as described above.

 8. Women of childbearing potential must have a negative pregnancy test at the baseline
 visit.

 9. Willingness to participate in medical photography with end use by Pfizer for
 publication and medical education purposes

 10. Subject and/or parent/ legal guardian has voluntarily signed and dated an informed
 consent form and assent form, if applicable, approved by Partners Institutional Review
 Board (IRB) indicating that he or she understands the purpose of and procedures
 required for the study and is willing to participate in the study (including
 photography consent).

 Exclusion Criteria:

 1. Clinically significant medical disorder, condition, or disease including other
 dermatologic conditions that may interfere with study assessments and photographs.

 2. Recent psychiatric condition (within the past year) or active suicidal ideation or
 behavior.

 3. Unstable AD (not having stable severity over the past month).

 4. Significant active infection requiring systemic antibiotics.

 5. Treatment with topical corticosteroids or topical calcineurin inhibitors within 2
 weeks of the baseline visit.

 6. Having used any of the following treatments within 4 weeks before the baseline visit,
 or any condition that, in the opinion of the investigator, is likely to require
 immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids,
 cyclosporine, mycophenolate-mofetil, interferon gamma, Janus kinase inhibitors,
 azathioprine, methotrexate, etc.) during the study.

 7. Treatment with biologics within 5 half-lives (if known) or 16 weeks before the
 baseline visit, whichever is longer.

 8. Subject with any planned surgical or medical procedure that would overlap with study
 participation from screening through end of study

 9. Currently has a malignancy or has a history of malignancy within 5 years before
 screening (except for a nonmelanoma skin cancer that has been adequately treated).

 10. Is pregnant, nursing, or planning a pregnancy (women).

 11. Previous failure of efficacy following crisaborole use.

 12. History of angioedema or anaphylaxis to topical products.

 13. Known allergies, hypersensitivity, or intolerance to crisaborole or its components.

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