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Comparison of Cathelicidin Expression in Skin and Saliva in Patients With Atopic Dermatitis and Psoriasis

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ClinicalTrials.gov Identifier: NCT00407979
Recruitment Status : Completed
First Posted : December 5, 2006
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Brief Summary:
Cathelicidins are small proteins in the human body that protect against infection. The purpose of this study is to determine if the amount of cathelicidins and other small proteins found in saliva can predict the amount of these in the skin of people who have acute atopic dermatitis (AD) or psoriasis.

Condition or disease
Atopic Dermatitis Psoriasis

Detailed Description:

People with AD or psoriasis are very sensitive to skin infections and inflammations. A group of small proteins known as cathelicidins are known to be responsible for immune defense against such infections. People with AD or psoriasis seem to be missing these proteins from their skin. The purpose of this study is to determine if the amount of cathelicidins and other small proteins in saliva is a predictor for the amount found in the skin.

This is a single visit observational study. People with AD or psoriasis, as well as healthy participants, are being recruited for this study. Participants will provide a detailed medical history and undergo a physical examination. In addition, saliva and blood collection, and skin punch biopsies will be performed.


Study Design
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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Analysis and Correlation of Cathelicidin Expression in Skin and Saliva of Subjects With Atopic Dermatitis and Psoriasis
Study Start Date : July 2005
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Psoriasis
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
People with Atopic Dermatitis
People with Psoriasis
Generally healthy people
People with Atopic Dermatitis and Eczema Herpeticum


Outcome Measures
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Primary Outcome Measures :
  1. To measure the local and systemic expression of cathelicidin (hCAP18/LL-37) in subjects with ADEH-, ADEH+, psoriasis, and in normal controls. [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. To determine whether the relative abundance of cathelicidins (hCAP18/LL-37) in the skin correlates with the expression in saliva and/or blood. [ Time Frame: 18 months ]

Biospecimen Retention:   Samples With DNA
Blood, skin, and saliva samples will be retained

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Generally healthy individuals
Criteria

Inclusion Criteria:

  • Diagnosis of typical AD for at least 6 months as defined by ADVN standardized diagnostic criteria OR diagnosis of typical plaque psoriasis for at least 6 months
  • ADEH participants as defined by ADVN standardized diagnostic criteria
  • Healthy participants with no personal or family history of food allergy, AD, asthma, or allergic rhinitis
  • Persons residing in the US
  • Healthy individuals with no systemic disorders as outlined in the exclusion criteria
  • Subjects 18 to 70 years of age
  • Male or female

Exclusion Criteria for All Participants:

  • Under 18 or over 70 years of age
  • Presence of allergic hypersensitivity without stringent AD features, allowing only a presumptive diagnosis of AD
  • Presence of AD with exfoliative erythroderma
  • Presence of psoriasis with exfoliative erythroderma or presence of guttate psoriasis, primary palmoplantar psoriasis, or pustular psoriasis
  • Ongoing dental disease (e.g., gingivitis)
  • Bleeding disorder
  • Presence of AD or psoriasis in which temporarily stopping current medications would cause worsening of the disease (Participants with active ADEH will be allowed to continue medication)
  • Systemic immunosuppressive or chemotherapeutic agents, anti-inflammatory biologics (e.g., alefacept, etanercept), or oral calcineurin inhibitors within 30 days of screening visit
  • Topical corticosteroids, oral or topical antibiotics, oral antivirals, immune enhancers (e.g., imiquimod), or topical calcineurin inhibitors within 7 days prior to screening visit (Participants with active ADEH will be allowed to continue medication)
  • Receiving phototherapy (e.g., ultraviolet light B [UVB], psoralen plus ultraviolet light A [PUVA]) within 30 days of study entry
  • Autoimmune disease or immunodeficiency
  • Active fungal, bacterial, or viral infections (Except ADEH subjects)
  • Active systemic cancer. Participants with uncomplicated nonmelanoma skin cancer are not excluded.
  • Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the study
  • Diabetic requiring medication
  • Pregnancy or breastfeeding
  • Inability or unwillingness of a participant to give written informed consent
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407979


Locations
United States, California
University of California, San Diego
San Diego, California, United States, 92161
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Richard Gallo, MD, PhD University of California, San Diego
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
National Institute of Allergy and Infectious Diseases (NIAID)  This link exits the ClinicalTrials.gov site
Division of Allergy, Immunology, and Transplantation (DAIT)  This link exits the ClinicalTrials.gov site

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SDY5
ImmPort study identifier is SDY5
Study design, -schedule of events, -demographics, -adverse events, -interventions, -files  This link exits the ClinicalTrials.gov site
Identifier: SDY5
ImmPort study identifier is SDY5

Publications of Results:

Other Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00407979     History of Changes
Other Study ID Numbers: DAIT ADVN CATH 02
DAIT-ADVN-CATH-02
First Posted: December 5, 2006    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.

Additional relevant MeSH terms:
Psoriasis
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases, Papulosquamous
Skin Diseases
 Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases