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
|
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Condition or disease |
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Atopic Dermatitis 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.
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 |

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

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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 |
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

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
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 |
Principal Investigator: | Richard Gallo, MD, PhD | University of California, San Diego |
Additional Information:
Study Data/Documents: Individual Participant Data Set

ImmPort study identifier is 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 |