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

December 13, 2007 updated by: Novartis
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States
        • Mount Sinai School of Medicine
      • New York, New York, United States
        • New York University Hospital
    • Virginia
      • Norfolk, Virginia, United States
        • Virginia Clinical Research, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion (ACTUAL)

June 1, 2005

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

July 5, 2005

First Posted (ESTIMATE)

July 6, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

December 17, 2007

Last Update Submitted That Met QC Criteria

December 13, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASM981C2436

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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