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Comparison of Cathelicidin Expression in Skin and Saliva in Patients With Atopic Dermatitis and Psoriasis
This study has been completed.
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00407979
First received: December 4, 2006
Last updated: January 10, 2017
Last verified: January 2017
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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 ]
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 ]
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 (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
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
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, 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
Additional Information:
Publications:
Study Data/Documents: Individual Participant Data Set
Identifier: SDY5
ImmPort study identifier is SDY5
ImmPort study identifier is SDY5
Study design, -schedule of events, -demographics, -adverse events, -interventions, -files
Identifier: SDY5
ImmPort study identifier is SDY5
ImmPort study identifier is SDY5
| 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 |
| Study First Received: | December 4, 2006 |
| Last Updated: | January 10, 2017 |
| Individual Participant Data | |
| 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:
|
Dermatitis Psoriasis Dermatitis, Atopic Eczema Skin Diseases Skin Diseases, Papulosquamous |
Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on June 22, 2017