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Molecular and Cellular Characterization of Spongiotic Dermatitis (Spongiotic)

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ClinicalTrials.gov Identifier: NCT00371163
Recruitment Status : Completed
First Posted : September 1, 2006
Last Update Posted : April 22, 2015
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of California, Davis

Study Description
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Brief Summary:

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 or disease
Atopic Dermatitis Psoriasis Contact Dermatitis

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:

  1. Identification of genes differentially expressed in atopic dermatitis, contact dermatitis, and psoriasis by microarray analyses.
  2. Confirmation of protein expression profiles in atopic and contact dermatitis, and psoriasis by immunohistochemical analyses.
  3. 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.


Study Design
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Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Molecular and Cellular Characterization of Spongiotic Dermatitis
Study Start Date : September 2006
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Contact Dermatitis
Males or females with contact dermatitis
Psoriasis
Males or females with psoriasis
No skin disease
Males or females with no skin diseases
Atopic Dermatitis
Males of females with atopic dermatitis


Outcome Measures
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Primary Outcome Measures :
  1. Identification of disease-specific potential diagnostic markers in plasma and PBMC. [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Males or females aged 18-55 with either contact dermatitis, psoriasis, atopic dermatitis, or no skin disease.
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00371163


Locations
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United States, California
UC Davis Department of Dermatology
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
Genentech, Inc.
Investigators
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Principal Investigator: Fu-Tong Liu, M.D., Ph.D. University of California, Davis
More Information
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Additional Information:
University of California-Davis Department of Dermatology Clinical Research  This link exits the ClinicalTrials.gov site

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00371163     History of Changes
Other Study ID Numbers: 200614530
First Posted: September 1, 2006    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015

Keywords provided by University of California, Davis:
Identification of genes by microarray analyses.

Additional relevant MeSH terms:
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Psoriasis
Dermatitis
Dermatitis, Atopic
Eczema
Dermatitis, Contact
Skin Diseases, Papulosquamous
Skin Diseases
 Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases