Effect of Pimecrolimus Cream on Cathelicidin Levels in Subjects With Eczema - Full Text View

Sponsor:	University of California, San Diego
Collaborator:	Novartis
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00946478

Purpose

The purpose of this study is to determine the effect of topical pimecrolimus on the immune system by assessing the levels of antimicrobial peptides in the skin of patients with eczema. It is hypothesized that pimecrolimus applied topically will repair the body's immune system in patients with eczema by increasing antimicrobial peptides.

Condition	Intervention
Atopic Dermatitis	Drug: Pimecrolimus Other: Vehicle cream

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	A Three-week, Double-blind, Randomized Study to Evaluate the Effect of Pimecrolimus Cream 1% on Cathelicidin Expression in the Skin of Subjects With Atopic Dermatitis

Resource links provided by NLM:

MedlinePlus related topics: Eczema

Drug Information available for: Pimecrolimus

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:

To determine the effect of pimecrolimus on the antimicrobial peptide cathelicidin in adult skin from patients with AD [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the effect of pimecrolimus on HBD-2, HBD-3, IL-13, and BCL-3 in adult skin from patients with AD [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:

40

Arms	Assigned Interventions
Pimecrolimus: Active Comparator	Drug: Pimecrolimus 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1. Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit).
Vehicle cream: Sham Comparator	Other: Vehicle cream 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1. Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit).

Arms

Assigned Interventions

Pimecrolimus: Active Comparator

Drug: Pimecrolimus

20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.

Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit).

Vehicle cream: Sham Comparator

Other: Vehicle cream

20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.

Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit).

Detailed Description:

Patients with atopic dermatitis (AD) have higher rates of skin infections from viruses and bacteria. They also have an impaired innate immune system. Antimicrobial peptides are a component of the innate immune system which are decreased in atopics. In vitro, pimecrolimus has demonstrated its ability to increase antimicrobial peptides. This study will examine the ability of pimecrolimus to increase antimicrobial peptides in vivo in AD patients. Thus, the study will yield a better understanding of the role of pimecrolimus in regulating the immune system in atopics.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-70 years
Target lesion IGA ≥2
Target IGA=0 (for non-lesional site)
Male or female of any race and ethnicity
Chronic AD for more than one year duration
Subject of child-bearing potential must be willing to practice effective birth control during the study
Subject agrees to comply with study requirements and attend all required visits.

Exclusion Criteria:

Patients ≥ 18 years of age with only AD of the face
Women of childbearing potential not using the contraception method(s) specified in this study (abstinence, IUD, diaphragm, oral contraceptives)
Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
Hypersensitivity to pimecrolimus cream or any excipient of the cream
Subject has a skin disorder in addition to dermatitis in the areas to be treated
Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
Pregnant or nursing females
Immunocompromised patient (e.g., lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome), or with a history of active or malignant disease (excluding non-melanoma skin cancer)
History of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
Patients known to be non-compliant with a medication regimen
Subjects with significant concurrent medical condition(s) at screening that in the view of the investigator prohibits participation in the study (e.g., severe concurrent allergic disease, condition associated with malignancy, and condition associated with immunosuppression)
Active viral or fungal skin infections at the target areas
Previous participation in this study
Ongoing participation in another investigational trial
Use of any oral or topical antibiotic during the study and up to one week prior to entering the study
Use of any local therapy for AD less than one week prior to screening
Use of any systemic immunosuppressive therapy for AD less than four weeks prior to screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946478

Contacts

Contact: Jeremiah Miller, MD

858.657.7192

jam011@ucsd.edu

Locations

United States, California
University of California, San Diego Thornton Hospital
La Jolla, California, United States, 92037

Sponsors and Collaborators

University of California, San Diego

Novartis

Investigators

Principal Investigator:

Richard Gallo, MD, PhD

University of California, San Diego

More Information

No publications provided

Responsible Party:	( Jeremiah Miller, MD, Research Fellow )
Study ID Numbers:	UCSDMED
Study First Received:	July 24, 2009
Last Updated:	July 24, 2009
ClinicalTrials.gov Identifier:	NCT00946478 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, San Diego:

atopic dermatitis
elidel
pimecrolimus
CASM981

immunity
cathelicidin
antimicrobial peptide
eczema

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dermatitis, Atopic
Immunologic Factors
Physiological Effects of Drugs
Tacrolimus
Hypersensitivity
Sensory System Agents
Therapeutic Uses
Skin Diseases, Eczematous
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Skin Diseases, Genetic
Dermatologic Agents

Dermatitis
Immune System Diseases
Skin Diseases
Pimecrolimus
Immunosuppressive Agents
Pharmacologic Actions
Genetic Diseases, Inborn
Analgesics, Non-Narcotic
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010