Molecular and Cellular Characterization of Spongiotic Dermatitis
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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 |
- 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) |
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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.
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 |
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.
-
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| United States, California | |
| UC Davis Department of Dermatology | |
| Sacramento, California, United States, 95816 | |
| 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 May 19, 2013