Effect of Pimecrolimus Cream on Cathelicidin Levels in Subjects With Eczema

NCT ID: NCT00946478

Last Updated: 2014-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-05-31

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pimecrolimus

Group Type: ACTIVE_COMPARATOR

Pimecrolimus

Intervention Type: DRUG

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).

Vehicle cream

Group Type: SHAM_COMPARATOR

Vehicle cream

Intervention Type: OTHER

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).

Interventions

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. 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: DRUG

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. 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

Other Intervention Names

Elidel; CASM 981

Eligibility Criteria

Inclusion Criteria

1. Age 18-70 years

2. Target lesion IGA ≥2

3. Target IGA=0 (for non-lesional site)

4. Male or female of any race and ethnicity

5. Chronic AD for more than one year duration

6. Subject of child-bearing potential must be willing to practice effective birth control during the study

7. Subject agrees to comply with study requirements and attend all required visits.

Exclusion Criteria

1. Patients ≥ 18 years of age with only AD of the face

2. Women of childbearing potential not using the contraception method(s) specified in this study (abstinence, IUD, diaphragm, oral contraceptives)

3. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study

4. Hypersensitivity to pimecrolimus cream or any excipient of the cream

5. Subject has a skin disorder in addition to dermatitis in the areas to be treated

6. Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier

7. Pregnant or nursing females

8. Immunocompromised patient (e.g., lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome), or with a history of active or malignant disease (excluding non-melanoma skin cancer)

9. History of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol

10. Patients known to be non-compliant with a medication regimen

11. 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)

12. Active viral or fungal skin infections at the target areas

13. Previous participation in this study

14. Ongoing participation in another investigational trial

15. Use of any oral or topical antibiotic during the study and up to one week prior to entering the study

16. Use of any local therapy for AD less than one week prior to screening

17. Use of any systemic immunosuppressive therapy for AD less than four weeks prior to screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Richard Gallo

Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Gallo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California, San Diego - Dept of Dermatology

La Jolla, California, United States

Countries

United States

Other Identifiers

UCSDMED

Identifier Type: -

Identifier Source: org_study_id