Effects of Pimecrolimus Cream 1% on the Molecular and Cellular Profile of Adult Male Patients With Atopic Dermatitis

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis
• Treatments: Pimecrolimus; Tacrolimus

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)