Please select the eligibility criteria that correspond to the clinical trial below.
Title: APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis
Brief Summary: This is an observational study to assess the long-term safety of Protopic® Ointment for the treatment of atopic dermatitis. Patients whose ages are/were \< 16 years at the time of first tacrolimus ointment exposure are eligible to participate. No drug is distributed during this observational trial.


Options:
A: Inclusion Criteria:

* Clinical diagnosis of atopic dermatitis that has been clinically stable for ≥1 month
* Total body surface area (BSA) of atopic dermatitis involvement ≤35%, excluding involvement of the face, scalp, and groin
* Presence of two (2) comparable target lesions
* Willing and able to apply study medications as directed, comply with study instructions, and commit to attending all visits
* Females of childbearing potential must use at least one highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use highly effective methods of birth control during the study.

Exclusion Criteria:

* Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
* Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation
* Significant confounding conditions as assessed by study doctor
* History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
* Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
* Pregnancy or lactation
B: Inclusion Criteria:

* Male or female subjects age 2-64.
* Stable or worsening atopic dermatitis affecting 5% or greater body surface area. Face and genital areas can be included in the body surface area determination and treatment area.
* The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
* The ability to understand and sign a written informed consent/assent form, which must be obtained prior to treatment.

Exclusion Criteria:

* Known allergy to crisaborole or to any component of the formulations.
* The use of systemic therapy for atopic dermatitis within the past 4 weeks.
* Use of prescription topical therapy for atopic dermatitis (e.g., corticosteroids or retinoids) within the past 2 weeks.
* Use of any investigational therapy within the past 4 weeks.
* Pregnant females, females who are breast feeding, or females of childbearing potential who are not practicing an acceptable method of birth control (abstinence, birth control pill/patch, barrier with spermicidal jelly, IUD, etc.), as determined by the investigator. Acceptable contraception must be used during the entire study. A pregnancy test will be performed on females of childbearing potential at baseline and at 6 month and 12 month.
* Any other condition, which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
C: Inclusion Criteria:

Aged ≥ 3 months at the screening visit to \< 24 months on baseline/Day 1, diagnosed with AD

Exclusion Criteria:

Subjects with any clinically significant dermatological condition or disease (including active or potentially recurrent non-AD dermatological conditions that overlap with AD such as Netherton Syndrome)
D: Inclusion Criteria:

* Subjects who first used Protopic® 0.03% or 0.1% before they were sixteen years of age and were treated for at least 6 weeks for the treatment of Atopic dermatitis may enroll into the study.

Answer: D