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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00117377

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

23.3

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Pimecrolimus Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2004

Actual Study Completion Date :

Jun 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Pimecrolimus	Drug: Pimecrolimus Pimecrolimus cream 1 % bid Other Names: Elidel
Placebo Comparator: 2 Placebo control twice daily application	Drug: Placebo Placebo application bid

Arm

Intervention/Treatment

Experimental: 1

Pimecrolimus

Drug: Pimecrolimus

Pimecrolimus cream 1 % bid

Other Names:

Elidel

Placebo Comparator: 2

Placebo control twice daily application

Drug: Placebo

Placebo application bid

Outcome Measures

Primary Outcome Measures

Determining whether pimecrolimus cream has an effect on the cellular and molecular profile of atopic dermatitis skin, which is cleared of lesions and is otherwise clinically normal. []

Secondary Outcome Measures

Identifying cellular and molecular changes in skin in an acute phase of atopic dermatitis []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country
1	Mount Sinai School of Medicine	New York	New York	United States
2	New York University Hospital	New York	New York	United States
3	Virginia Clinical Research, Inc	Norfolk	Virginia	United States