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

• ClinicalTrials.gov Identifier: NCT00117377
• Recruitment Status: Completed
• First Posted: July 6, 2005
• Last Update Posted: December 17, 2007
• Sponsor: Novartis
• Information provided by: Novartis

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 (Clinical Trial)
• Enrollment: 70 participants
• 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: April 2004
• Actual Study Completion Date: June 2005

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. Identifying cellular and molecular changes in skin in an acute phase of atopic dermatitis

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

United States, New York

Mount Sinai School of Medicine

New York, New York, United States

New York University Hospital

New York, New York, United States

United States, Virginia

Virginia Clinical Research, Inc

Norfolk, Virginia, United States

Sponsors and Collaborators

Novartis

Investigators

• Study Chair: Novartis Pharmaceuticals; Novartis Pharmaceuticals

More Information

• Responsible Party: External Affairs, Novartis
• ClinicalTrials.gov Identifier: NCT00117377
• Other Study ID Numbers: CASM981C2436
• First Posted: July 6, 2005
• Last Update Posted: December 17, 2007
• Last Verified: December 2007

Keywords provided by Novartis:

Atopic dermatitis, pimecrolimus, cellular, molecular

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pimecrolimus; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action