Molecular and Cellular Characterization of Spongiotic Dermatitis - Full Text View

Sponsors and Collaborators:	University of California, Davis Genentech
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00371163

Purpose

Spongiotic dermatitis is the histopathologic diagnosis commonly issued by dermatopathologists that encompasses atopic dermatitis, contact dermatitis, and other forms of eczematous dermatitis.

The information obtained will assist in development of diagnostic methods for differentiation of the types of spongiotic dermatitis. This study also has the potential to lead to the dissection of pathologic pathways involved in these diseases and development of novel therapeutic agents.

Condition	Intervention	Phase
Atopic Dermatitis Psoriasis Contact Dermatitis	Procedure: microarray analyses.	Phase II Phase III

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Molecular and Cellular Characterization of Spongiotic Dermatitis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

Identification of disease-specific potential diagnostic markers in plasma and PBMC. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	September 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Identification of genes differentially expressed in atopic dermatitis, contact dermatitis, and psoriasis by microarray analyses. Confirmation of protein expression profiles in atopic and contact dermatitis, and psoriasis by immunohistochemical analyses. Identification of disease-specific potential diagnostic markers in plasma and PBMC.

Detailed Description:

Spongiotic dermatitis is the histopathologic diagnosis commonly issued by dermatopathologists that encompasses atopic dermatitis, contact dermatitis, and other forms of eczematous dermatitis. Atopic dermatitis is a chronic, relapsing inflammatory disease characterized by pruritic, scaly, red, eczematous skin lesions, and a personal or family history of atopy. Patients affected by atopic dermatitis experience significant morbidity from extreme pruritus, recurrent cutaneous infections, and extensive and/or disfiguring skin lesions. Allergic contact dermatitis typically manifests as pruritus and vesicular or eczematous lesions associated with direct exposure to environmental haptenic allergens.

The specific aims of this research are:

Identification of genes differentially expressed in atopic dermatitis, contact dermatitis, and psoriasis by microarray analyses.
Confirmation of protein expression profiles in atopic and contact dermatitis, and psoriasis by immunohistochemical analyses.
Identification of disease-specific potential diagnostic markers in plasma and PBMC.

The information obtained will assist in development of diagnostic methods for differentiation of the types of spongiotic dermatitis. This study also has the potential to lead to the dissection of pathologic pathways involved in these diseases and development of novel therapeutic agents.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Atopic Dermatitis: Subjects will be identified based on the Hanifin criteria of atopic dermatitis.

Subjects will be adults with a history of atopic dermatitis since childhood, who continue to have symptoms and signs of atopic dermatitis. They must have active lesions and should not be on systemic therapy.
Contact Dermatitis: Subjects will be adults with history of contact dermatitis to common allergens. They will undergo patch testing to common allergens and the sites of positive reactions will be considered as lesional skin.
Psoriasis: Subjects will be adults with chronic disease, who have active skin lesions with a characteristic morphology.

Subjects will be asked to discontinue topical medications at least to parts of the skin where biopsies will be taken, one week prior to biopsy.

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Exclusion Criteria:

Patients on systemic treatment of their skin diseases within the past one month.
A history of significant neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic diseases.
Abnormal hepatic function or renal function (creatinine or BUN is > 1.2 times the upper level of the normal range for the laboratory where the testing is done).
Abnormal blood counts (WBC < 4 x 103/mm3; platelet < 100 x 103/mm3; hemoglobin < 11g/dl).
History of alcohol or drug abuse.
Known hepatitis or HIV.
Pregnant women (as determined by serum pregnancy test).
Significant allergic or adverse reaction to local anesthetics.
Blood clotting disorder.
Faintness or vasovagal reaction with blood draws or procedures.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371163

Contacts

Contact: Fu- Tong Liu, M.D., PhD.	916-734-6795	fliu@ucdavis.edu
Contact: Jennifer Nava, CRC	916-734-1438	jennifer.nava@ucdmc.ucdavis.edu

Locations

United States, California
UC Davis Department of Dermatology	Recruiting
Sacramento, California, United States, 95816
Principal Investigator: Fu Tong Liu, M.D., PhD.

Sponsors and Collaborators

University of California, Davis

Genentech

Investigators

Principal Investigator:

Fu -Tong Liu, M.D., PhD.

Professor and Chair of UCDavis Dermatology

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of California Davis ( Fu-Tong Liu )
Study ID Numbers:	200614530-1
Study First Received:	August 30, 2006
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00371163 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

Identification of genes by microarray analyses.

Study placed in the following topic categories:

Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Psoriasis
Hypersensitivity, Immediate

Skin Diseases, Eczematous
Skin Diseases, Papulosquamous
Skin Diseases, Genetic
Dermatitis, Contact
Dermatitis

Additional relevant MeSH terms:

Hypersensitivity
Dermatitis, Atopic
Immune System Diseases
Genetic Diseases, Inborn
Skin Diseases
Psoriasis

Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous
Skin Diseases, Genetic
Dermatitis, Contact
Dermatitis

ClinicalTrials.gov processed this record on September 09, 2009