Comparison of Cathelicidin Expression in Skin and Saliva in Patients With Atopic Dermatitis and Psoriasis

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

Conditions: Atopic Dermatitis; Psoriasis

Study type: Observational

Funder types: NIH

Identifiers

NCT00407979

DAIT-ADVN-CATH-02

DAIT ADVN CATH 02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

80 participants in 4 patient groups

People with Atopic Dermatitis

People with Psoriasis

Generally healthy people

People with Atopic Dermatitis and Eczema Herpeticum