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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00407979
First received: December 4, 2006
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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
Atopic Dermatitis
Psoriasis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood, skin, and saliva samples will be retained


Enrollment: 80
Study Start Date: July 2005
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
People with Atopic Dermatitis
People with Psoriasis
Generally healthy people
People with Atopic Dermatitis and Eczema Herpeticum

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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: 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
Sponsors and Collaborators
Investigators
Principal Investigator: Richard Gallo, MD, PhD University of California, San Diego
  More Information

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, Contract No. HHSN266200400029C
Study First Received: December 4, 2006
Last Updated: April 1, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 01, 2014