Effect of Pimecrolimus Cream on Cathelicidin Levels in Subjects With Eczema

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Richard Gallo, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00946478
First received: July 24, 2009
Last updated: January 27, 2014
Last verified: January 2014
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Cathelicidin mRNA Expression Levels in Adult Skin From Patients With AD [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 40
Study Start Date: October 2009
Study Completion Date: May 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).


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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Richard Gallo, Chair, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00946478     History of Changes
Other Study ID Numbers: UCSDMED
Study First Received: July 24, 2009
Results First Received: December 10, 2013
Last Updated: January 27, 2014
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:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pimecrolimus
Tacrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014