Status:
COMPLETED
Effects of Pimecrolimus Cream 1% on the Molecular and Cellular Profile of Adult Male Patients With Atopic Dermatitis
Lead Sponsor:
Novartis
Conditions:
Atopic Dermatitis
Eligibility:
MALE
20+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00117377
Start Date
April 1 2004
End Date
June 1 2005
Last Update
December 17 2007
Active Locations (3)
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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