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

NCT ID: NCT00117377

Last Updated: 2007-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2005-06-30

Brief 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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis, pimecrolimus, cellular, molecular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Pimecrolimus

Group Type: EXPERIMENTAL

Pimecrolimus

Intervention Type: DRUG

Pimecrolimus cream 1 % bid

2

Placebo control twice daily application

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo application bid

Interventions

Pimecrolimus

Pimecrolimus cream 1 % bid

Intervention Type: DRUG

Placebo

Placebo application bid

Intervention Type: DRUG

Other Intervention Names

Elidel

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

Mount Sinai School of Medicine

New York, New York, United States

New York University Hospital

New York, New York, United States

Virginia Clinical Research, Inc

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

CASM981C2436

Identifier Type: -

Identifier Source: org_study_id