Please select the eligibility criteria that correspond to the clinical trial below.
Title: Five-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 to Less Than 12 Months of Age With Mild to Moderate Atopic Dermatitis
Brief Summary: The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than 12 months of age compared to topical corticosteroids (TCS).


Options:
A: Inclusion criteria

* Age 18-75 years
* AD according to the Hanifin and Rajka Criteria24
* AD for at least 3 years
* BMI ≤ 30 kg/m2
* Haemoglobin A1c (HbA1c) ≤ 42 mmol/mol (6.0%)
* Normal haemoglobin (men: 8.3-10.5 mmol/L and women 7.3-9.5 mmol/L. A 5% deviation will be allowed if the patient besides this is healthy)
* Informed consent
* In general patients should not be diagnosed with diseases that may affect or be affected by the study/treatment (evaluated by a doctor) (such as untreated skin infections, acne vulgaris (beside face region), a skin barrier defect, such as Netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous Graft Versus Host Disease, congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression, and Protopic ointment should not be applied to lesions that are considered to be potentially malignant or pre-malignant. Further patients should not suffer from kidney or liver disease/insufficiency. See the SPC for Protopic and Betnovate.)

Exclusion criteria

* Diagnosed diabetes mellitus
* Other chronic inflammatory diseases (including but not limited to rheumatoid arthritis, inflammatory bowel disease etc) beside AD and non-treatment demanding rhinitis or asthma (treated within the last 4 weeks)
* Pregnancy (a urine test will be done at every visit and birth control is required, see below\*)
* Breast feeding
* Treatment with drugs that might affect the glucose metabolism beside TCS within a month prior to the project
* Daily smoker, alcoholic, or drug abuser
* Hypersensitivity to Protopic or Betnovate
B: Inclusion Criteria:

* Adolescents aged ≥12 to 17 years, inclusive, and men and women aged ≥18 years.
* Participants diagnosed with Atopic Dermatitis (AD) as defined by the Hanifin and Rajka criteria.
* AD duration of at least 2 years.
* Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at screening and Baseline \[Vehicle Controlled (VC) Period\] and 0 to 4 at Week 8 \[Long-Term Safety (LTS) Period\].
* Participants with percentage of Body Surface Area (% BSA) (excluding scalp) of AD involvement of 3% to 20% at screening and Baseline (VC Period) and 0% to 20% at Week 8 (LTS Period).
* Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.
* Participants who have at least 1 "target lesion" that measures approximately 10 cm\^2 or more at screening and Baseline. Lesion must be representative of the participant's disease state and not be located on the hands, feet, or genitalia.
* Willingness to avoid pregnancy or fathering of children.

Exclusion Criteria:

* Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Baseline.
* Concurrent conditions and history of other diseases:

  * Immunocompromised.
  * Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Baseline.
  * Active acute bacterial, fungal, or viral skin infection within 1 week before Baseline.
  * Any other concomitant skin disorder, pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
  * Presence of AD lesions only on the hands or feet without prior history of involvement of other classical areas of involvement such as the face or the folds.
  * Other types of eczema.
* Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
* Use of any of the following treatments within the indicated washout period before Baseline:

  * 5 half-lives or 12 weeks, whichever is longer - biologic agents (eg. dupilumab).
  * 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg. mycophenolate or tacrolimus).
  * 2 weeks - immunizations and sedating antihistamines, unless on long-term stable regimen (nonsedating antihistamines are permitted).
  * 1 week - use of other topical treatments for AD (other than bland emollients). Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study.
* Participants who have previously received Janus kinase (JAK) inhibitors, systemic or topical.
* Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 2 weeks prior to Baseline and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant's AD.
* Positive serology test results at screening for Human Immunodeficiency Virus (HIV) antibody.
* Liver function tests: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 × upper limit of normal (ULN); alkaline phosphatase and/or bilirubin \> 1.5 × ULN (isolated bilirubin \> 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%).
* Pregnant or lactating participants, or those considering pregnancy.
* History of alcoholism or drug addiction within 1 year before screening or current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the administration schedule and study assessments.
* Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before Baseline with another investigational medication or current enrollment in another investigational drug protocol.
C: 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
D: Inclusion Criteria:

* Aged 3 to \< 12 months
* Diagnosis of AD fulfilling the diagnostic criteria of Seymour
* AD affecting at least 5% total body surface area
* Investigator's Global Assessment (IGA) score of 2 or 3, corresponding to mild-to-moderate disease at baseline
* Informed consent

Exclusion Criteria:

* Phototherapy, systemic therapy (e.g., immunosuppressants, cytostatics), systemic corticosteroids within 4 weeks
* Topical tacrolimus or pimecrolimus within 2 weeks
* Topical therapy (e.g., tar, topical corticosteroids) within 3 days
* Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease
* Active acute viral skin infection (e.g. herpes simplex, herpes zoster, chicken pox), and/or clinically infected AD
* Failure to thrive (e.g., weight or height/length below the 5th percentile) or developmental abnormalities such as head circumference less than 5th and more than 95th percentile
* Known hypersensitivity to any ingredient of pimecrolimus cream 1% or topical corticosteroids
* Clinical conditions other than AD that according to investigator can interfere with the evaluation

Answer: D