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

Psoriasis Clinical Trial

Official title:

Analysis and Correlation of Cathelicidin Expression in Skin and Saliva of Subjects With Atopic Dermatitis and Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00407979
• Other study ID #: DAIT ADVN CATH 02
• Secondary ID: DAIT-ADVN-CATH-0
• Status: Completed
• Phase: N/A
• First received: December 4, 2006
• Last updated: January 10, 2017
• Start date: July 2005
• Est. completion date: February 2009

Study information

• Verified date: January 2017
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Psoriasis

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Tomasinsig L, Zanetti M. The cathelicidins--structure, function and evolution. Curr Protein Pept Sci. 2005 Feb;6(1):23-34. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure the local and systemic expression of cathelicidin (hCAP18/LL-37) in subjects with ADEH-, ADEH+, psoriasis, and in normal controls.		18 months	No
Secondary	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	No

External Links

•   Division of Allergy, Immunology, and Transplantation (DAIT)
•   National Institute of Allergy and Infectious Diseases (NIAID)