Effect of Pimecrolimus Cream on Cathelicidin Levels in Subjects With Eczema

• ClinicalTrials.gov Identifier: NCT00946478
• Recruitment Status: Completed
• First Posted: July 27, 2009
• Results First Posted: March 10, 2014
• Last Update Posted: March 10, 2014
• Sponsor: University of California, San Diego
• Collaborator: Novartis
• Information provided by (Responsible Party): Richard Gallo, University of California, San Diego

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.

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: Pimecrolimus; Other: Vehicle cream	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: October 2009
• Actual Primary Completion Date: February 2011
• Actual Study Completion Date: May 2011

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Pimecrolimus	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. 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).; Other Names: Elidel; CASM 981
Sham Comparator: Vehicle cream	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. 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).

Outcome Measures

Primary Outcome Measures :

1. Cathelicidin mRNA Expression Levels in Adult Skin From Patients With AD [ Time Frame: 3 weeks ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

University of California, San Diego - Dept of Dermatology

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

• Responsible Party: Richard Gallo, Chair, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT00946478
• Other Study ID Numbers: UCSDMED
• First Posted: July 27, 2009
• Results First Posted: March 10, 2014
• Last Update Posted: March 10, 2014
• Last Verified: January 2014

Keywords provided by Richard Gallo, University of California, San Diego:

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

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pimecrolimus; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action