Molecular and Cellular Characterization of Spongiotic Dermatitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by University of California, Davis.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Genentech
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00371163
First received: August 30, 2006
Last updated: June 7, 2011
Last verified: June 2011
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Molecular and Cellular Characterization of Spongiotic Dermatitis

Resource links provided by NLM:


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 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: microarray analyses.

    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:

  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.

  Eligibility

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

-

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
UC Davis Department of Dermatology
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
Genentech
Investigators
Principal Investigator: Fu-Tong Liu, MD, PhD Professor and Chair of UC Davis Dermatology
  More Information

Additional Information:
No publications provided

Responsible Party: Fu-Tong Liu, MD, PhD, University of California Davis
ClinicalTrials.gov Identifier: NCT00371163     History of Changes
Other Study ID Numbers: 200614530-1
Study First Received: August 30, 2006
Last Updated: June 7, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 26, 2014