Clinical trial NCT00407979: Comparison of Cathelicidin Expression in Skin and Saliva in Patients With Atopic Dermatitis and Psoriasis
Official title: Analysis and Correlation of Cathelicidin Expression in Skin and Saliva of Subjects With Atopic Dermatitis and Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Psoriasis
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2006-12-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Generally healthy individuals

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.

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 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

Primary outcomes:
measure: To measure the local and systemic expression of cathelicidin (hCAP18/LL-37) in subjects with ADEH-, ADEH+, psoriasis, and in normal controls.
timeFrame: 18 months
Secondary outcomes:
measure: To determine whether the relative abundance of cathelicidins (hCAP18/LL-37) in the skin correlates with the expression in saliva and/or blood.
timeFrame: 18 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
affiliation: University of California, San Diego
name: Richard Gallo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tomasinsig L, Zanetti M. The cathelicidins--structure, function and evolution. Curr Protein Pept Sci. 2005 Feb;6(1):23-34. doi: 10.2174/1389203053027520.
citation: Schauber 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.