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Effect of Pimecrolimus Cream on Cathelicidin Levels in Subjects With Eczema

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pimecrolimus

Vehicle cream

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, elidel, pimecrolimus, CASM981, immunity, cathelicidin, antimicrobial peptide, eczema

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of California, San Diego - Dept of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Pimecrolimus

Vehicle cream

Arm Description

Outcomes

Primary Outcome Measures

Cathelicidin mRNA Expression Levels in Adult Skin From Patients With AD

Delta-delta CT values were measured using RT-PCR of cathelicidin mRNA in human biopsy samples at baseline, and then 3 weeks after treatment with either pimecrolimus or placebo

Secondary Outcome Measures

Full Information

NCT ID

NCT00946478

First Posted

July 24, 2009

Last Updated

January 27, 2014

Sponsor

University of California, San Diego

Collaborators

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00946478

Brief Title

Effect of Pimecrolimus Cream on Cathelicidin Levels in Subjects With Eczema

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

Novartis

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

atopic dermatitis, elidel, pimecrolimus, CASM981, immunity, cathelicidin, antimicrobial peptide, eczema

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pimecrolimus

Arm Type

Active Comparator

Arm Title

Vehicle cream

Arm Type

Sham Comparator

Intervention Type

Drug

Intervention Name(s)

Pimecrolimus

Other Intervention Name(s)

Elidel, CASM 981

Intervention Description

20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. 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).

Intervention Type

Other

Intervention Name(s)

Vehicle cream

Intervention Description

20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. 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).

Primary Outcome Measure Information:

Title

Cathelicidin mRNA Expression Levels in Adult Skin From Patients With AD

Description

Delta-delta CT values were measured using RT-PCR of cathelicidin mRNA in human biopsy samples at baseline, and then 3 weeks after treatment with either pimecrolimus or placebo

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Gallo, MD, PhD

Organizational Affiliation

University of California, San Diego

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, San Diego - Dept of Dermatology

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Effect of Pimecrolimus Cream on Cathelicidin Levels in Subjects With Eczema

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