effects of pimecrolimus cream 1% on the molecular and cellular profile of adult male patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to identify how pimecrolimus cream 1% modifies the molecular and cellular changes associated with the post-lesional phase of atopic dermatitis (ad). healthy volunteers and patients with atopic dermatitis will be studied.


Eligibility criteria:
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)

Keywords: atopic dermatitis, pimecrolimus, cellular, molecular