Study of Crisaborole Ointment 2% in Mild to Moderate Atopic Dermatitis

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label, Photo Documentation Study of Crisaborole Ointment 2% in Mild to Moderate Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Crisaborole 2% Top Oint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a male or female aged at least 2 years of age. Subject has confirmed clinical diagnosis of active atopic dermatitis (AD) according to the Hanifin and Rajka criteria. AD diagnosed at least 6 months prior to the screening visit and severity of disease has been stable for the past month. 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] Subject has a global ISGA of mild (2) or moderate (3) at the baseline visit. Subject must be willing to avoid excessive exposure to natural or artificial ultraviolet radiation. 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. Women of childbearing potential must have a negative pregnancy test at the baseline visit. Willingness to participate in medical photography with end use by Pfizer for publication and medical education purposes 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: Clinically significant medical disorder, condition, or disease including other dermatologic conditions that may interfere with study assessments and photographs. Recent psychiatric condition (within the past year) or active suicidal ideation or behavior. Unstable AD (not having stable severity over the past month). Significant active infection requiring systemic antibiotics. Treatment with topical corticosteroids or topical calcineurin inhibitors within 2 weeks of the baseline visit. 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. Treatment with biologics within 5 half-lives (if known) or 16 weeks before the baseline visit, whichever is longer. Subject with any planned surgical or medical procedure that would overlap with study participation from screening through end of study 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). Is pregnant, nursing, or planning a pregnancy (women). Previous failure of efficacy following crisaborole use. History of angioedema or anaphylaxis to topical products. Known allergies, hypersensitivity, or intolerance to crisaborole or its components. Participation in another clinical research study with an investigational drug within 4 weeks before randomization in this study

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Crisaborole<br>Crisaborole is a low molecular weight benzoxaborole PDE-4 inhibitor for the treatment of mild-to-moderate atopic dermatitis in adults and children 2 years and above. Crisaborole ointment 2% is topically applied as a thin layer twice daily for 4 weeks to all AD lesions. | Drug: Crisaborole 2% Top Oint<br>* Crisaborole is a low molecular weight benzoxaborole PDE-4 inhibitor for the treatment of mild-to-moderate atopic dermatitis in adults and children 2 years and above. Crisaborole ointment 2% is topically applied as a thin layer twice daily for 4 weeks to all AD lesions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to success (in days) on ISGA | Time to success (in days) on ISGA (to clear or almost clear with at least a 2-grade improvement) for intensive group through study completion, an average of 4 weeks, will be summarized by 25th percentile, median, and corresponding 95% CIs via Kaplan-Meier method. Kaplan-Meier plot will be provided as well. | At days 1, 8,15, 21 and 29 | 
| Time to success (by week) on ISGA | Time to success (by week) on ISGA (to clear or almost clear with at least a 2-grade improvement) for all subjects through study completion, an average of 4 weeks, will be summarized by 25th percentile, median, and corresponding 95% CI via Kaplan-Meier method. Kaplan-Meier plot will be provided as well. (pooled all subjects, at days 1, 8,15, 21 and 29) | At days 1, 8,15, 21 and 29 |