Inclusion Criteria:
Inclusion criteria for patients with atopic dermatitis:
- Outpatient at screening
- Adult male >20 years old
- Diagnosis of AD fulfilling the Hannifin and Rajka criteria
- Mild to moderate AD (Investigator Global Assessment [IGA] 2-3; localized eczema area and severity index [EASI] 1-8)
- AD affecting both arms and/or legs >10cm2 per target area
- Willing to undergo 4 mm serial punch biopsies
- Patient history of AD for at least 3 years
Inclusion criteria for healthy volunteers:
- Volunteers must be males >20 years of age
- Volunteers must be in good health, as determined by past medical history, physical examination, and vital signs
Exclusion Criteria:
Exclusion criteria for patients with atopic dermatitis:
- Concurrent diseases/conditions and history of other diseases/conditions
- Are immunocompromised or have a history of malignant disease
- Have a history of rheumatic fever, heart valve replacement, prosthetic joints or other prosthetic constituents
- Have concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the study evaluation
- Have previously reported poor or no clinical response to topical tacrolimus ointment (Protopic®) or pimecrolimus cream (Elidel®)
- Have active skin infections
- Present with clinical conditions other than atopic dermatitis that can interfere with the study treatment
- Present with severe medical condition(s) that, in the opinion of the investigator, prohibits participation in the study
- Are maintained on emollients that contain supplementary ingredients such as urea, alpha or beta-hydroxy acids, fruit acids, vitamins A, D or E
- Have received phototherapy (e.g. UVA, UVB) or systemic therapy (e.g. immunosuppressants, cytostatics) known or suspected to have an effect on AD within 4 weeks of Visit 1 (screening)
- Have received systemic corticosteroids ([CS] e.g. oral, intravenous, intraarticular, rectal) within 4 weeks of Visit 1 (screening). Patients on a stable maintenance dose of inhaled or intranasal CS may participate
- Were treated with topical therapy, including topical calcineurin inhibitors (e.g. corticosteroids, tar) known or suspected to have an effect on AD during the current acute episode
- Were treated with antihistamines within 7 days of Visit 1
- Known serious adverse reactions or hypersensitivity to anesthetics such as lidocaine or mepivacaine
- Excluded investigational drugs/hypersensitivity
- Have received investigational drugs within 8 weeks of the first application of study drug or planned use of other investigational drugs during participation in this study
- Have known hypersensitivity to any ingredient of the pimecrolimus cream 1% or this class of study drug
Exclusion criteria for healthy volunteers:
- Erythrodermic patients, patients with Netherton's syndrome
- Personal or family history of atopy (asthma, allergic rhinitis, atopic dermatitis)
- Clinically significant findings during the physical examination
- Have a history of rheumatic fever, heart valve replacement, prosthetic joints or other prosthetic constituents e.g. lens implants or hip joints
- Volunteers with known serious adverse reactions or hypersensitivity to anesthetics such as lidocaine or mepivacaine
- Participation in any clinical trial within one month prior to current trial
- History of immunocompromise
- History of positive hepatitis B surface antigen (HBsAg) or hepatitis C test result
- Use of corticosteroids within 4 weeks prior to baseline
- Were treated with antihistamines within 7 days of Visit 1
- Phototherapy within 4 weeks prior to baseline
- Topical therapy within 5 weeks prior to the study
- Treatment with nephrotoxic drugs within 2 weeks prior to baseline (aminoglycosides, amphotericin B, colchicine)