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

January 10, 2017 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Analysis and Correlation of Cathelicidin Expression in Skin and Saliva of Subjects With Atopic Dermatitis and Psoriasis

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161
        • University of California, San Diego
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Generally healthy individuals

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

December 4, 2006

First Submitted That Met QC Criteria

December 4, 2006

First Posted (Estimate)

December 5, 2006

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAIT ADVN CATH 02
  • DAIT-ADVN-CATH-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: SDY5
    Information comments: ImmPort study identifier is SDY5
  2. Study design, -schedule of events, -demographics, -adverse events, -interventions, -files
    Information identifier: SDY5
    Information comments: ImmPort study identifier is SDY5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psoriasis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe