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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00117377
• Other study ID #: CASM981C2436
• Status: Completed
• Phase: Phase 4
• First received: June 30, 2005
• Last updated: December 13, 2007
• Start date: April 2004
• Est. completion date: June 2005

Study information

• Verified date: December 2007
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Austria: Federal Ministry for Health and WomenGermany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Pimecrolimus
Pimecrolimus cream 1 % bid
• Placebo
Placebo application bid

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Identifying cellular and molecular changes in skin in an acute phase of atopic dermatitis