Atopic DermatitisSpongioticNCT00371163
Molecular and Cellular Characterization of Spongiotic Dermatitis
An observational study of Atopic Dermatitis and Psoriasis, run by University of California, Davis at 1 site in United States.
Trial summary
Spongiotic dermatitis is the histopathologic diagnosis commonly issued by dermatopathologists that encompasses atopic dermatitis, contact dermatitis, and other forms of eczematous dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Psoriasis, Contact Dermatitis
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Males or females aged 18-55 with either contact dermatitis, psoriasis, atopic dermatitis, or no skin disease.
Who may be able to join
- 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.
- -
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Department of Dermatology
Sacramento, California, 95816
About this study
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.
Read the 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.
- Conditions
- Atopic Dermatitis, Psoriasis, Contact Dermatitis
- Keywords
- Identification of genes by microarray analyses.
- Medical subject headings
- Dermatitis, Atopic, Psoriasis, Dermatitis, Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of disease-specific potential diagnostic markers in plasma and PBMC.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Fu-Tong Liu, M.D., Ph.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371163
- Sponsor's protocol ID
- 200614530
- Acronym
- Spongiotic
- Status last verified
- Apr 2015
- First submitted
- 30 Aug 2006
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Cellular Characterization of Spongiotic Dermatitis
- ClinicalTrials.gov ID
- NCT00371163
- Acronym / sponsor ID
- Spongiotic / 200614530
- Conditions
- Atopic Dermatitis, Psoriasis, Contact Dermatitis
- Keywords
- Identification of genes by microarray analyses.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Sep 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Males or females aged 18-55 with either contact dermatitis, psoriasis, atopic dermatitis, or no skin disease.
Key inclusion criteria (5 listed)
- 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.
- -
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of disease-specific potential diagnostic markers in plasma and PBMC.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- University of California-Davis Department of Dermatology Clinical ResearchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fu-Tong Liu, M.D., Ph.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Psoriasis, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of disease-specific potential diagnostic markers in plasma and PBMC. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2015.