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
2 other identifiers
observational
80
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2005
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 4, 2006
CompletedFirst Posted
Study publicly available on registry
December 5, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedJanuary 11, 2017
January 1, 2017
3.6 years
December 4, 2006
January 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
To measure the local and systemic expression of cathelicidin (hCAP18/LL-37) in subjects with ADEH-, ADEH+, psoriasis, and in normal controls.
18 months
Secondary Outcomes (1)
To determine whether the relative abundance of cathelicidins (hCAP18/LL-37) in the skin correlates with the expression in saliva and/or blood.
18 months
Study Arms (4)
People with Atopic Dermatitis
People with Psoriasis
Generally healthy people
People with Atopic Dermatitis and Eczema Herpeticum
Eligibility Criteria
Generally healthy individuals
You may qualify if:
- 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
You may not qualify if:
- Subjects 18 to 70 years of age
- Male or female
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of California, San Diego
San Diego, California, 92161, United States
National Jewish Health
Denver, Colorado, 80206, United States
Related Publications (2)
Tomasinsig L, Zanetti M. The cathelicidins--structure, function and evolution. Curr Protein Pept Sci. 2005 Feb;6(1):23-34. doi: 10.2174/1389203053027520.
PMID: 15638766BACKGROUNDSchauber J, Dorschner RA, Yamasaki K, Brouha B, Gallo RL. Control of the innate epithelial antimicrobial response is cell-type specific and dependent on relevant microenvironmental stimuli. Immunology. 2006 Aug;118(4):509-19. doi: 10.1111/j.1365-2567.2006.02399.x.
PMID: 16895558RESULT
Related Links
Biospecimen
Blood, skin, and saliva samples will be retained
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Gallo, MD, PhD
University of California, San Diego
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2006
First Posted
December 5, 2006
Study Start
July 1, 2005
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
January 11, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share
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.