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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 1
    • Pimecrolimus
  • Placebo Comparator: 2
    • Placebo control twice daily application

Clinical Trial Outcome Measures

Primary 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 Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: Male

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Novartis
  • Provider of Information About this Clinical Study
    • External Affairs, Novartis
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Chair, Novartis Pharmaceuticals

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