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

NCT ID: NCT00407979

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2009-02-28

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.

Conditions

Atopic Dermatitis; Psoriasis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

People with Atopic Dermatitis

No interventions assigned to this group

People with Psoriasis

No interventions assigned to this group

Generally healthy people

No interventions assigned to this group

People with Atopic Dermatitis and Eczema Herpeticum

No interventions assigned to this group

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

Exclusion Criteria

• 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.
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Gallo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California, San Diego

San Diego, California, United States

National Jewish Health

Denver, Colorado, United States

Countries

United States

References

Tomasinsig L, Zanetti M. The cathelicidins--structure, function and evolution. Curr Protein Pept Sci. 2005 Feb;6(1):23-34. doi: 10.2174/1389203053027520.

Reference Type: BACKGROUND

PMID: 15638766 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16895558 (View on PubMed)

Related Links

https://www.niaid.nih.gov/

National Institute of Allergy and Infectious Diseases (NIAID)

https://www.niaid.nih.gov/about/dait

Division of Allergy, Immunology, and Transplantation (DAIT)

Other Identifiers

DAIT-ADVN-CATH-02

Identifier Type: -

Identifier Source: secondary_id

DAIT ADVN CATH 02

Identifier Type: -

Identifier Source: org_study_id