Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

December 4, 2006
April 1, 2014
July 2005
February 2009   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00407979 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
Not Provided
 
Comparison of Cathelicidin Expression in Skin and Saliva in Patients With Atopic Dermatitis and Psoriasis
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood, skin, and saliva samples will be retained

Non-Probability Sample

Generally healthy individuals

  • Atopic Dermatitis
  • Psoriasis
Not Provided
  • People with Atopic Dermatitis
  • People with Psoriasis
  • Generally healthy people
  • People with Atopic Dermatitis and Eczema Herpeticum

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00407979
DAIT ADVN CATH 02, Contract No. HHSN266200400029C
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Richard Gallo, MD, PhD University of California, San Diego
National Institute of Allergy and Infectious Diseases (NIAID)
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP