NCT00371163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

6.3 years

First QC Date

August 30, 2006

Last Update Submit

April 20, 2015

Conditions

Atopic DermatitisPsoriasisContact Dermatitis

Keywords

Identification of genes by microarray analyses.

Outcome Measures

Primary Outcomes (1)

  • Identification of disease-specific potential diagnostic markers in plasma and PBMC.

    2 years

Study Arms (4)

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

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Males or females aged 18-55 with either contact dermatitis, psoriasis, atopic dermatitis, or no skin disease.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Links

MeSH Terms

Conditions

Dermatitis, AtopicPsoriasisDermatitis, Contact

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSkin Diseases, Papulosquamous

Study Officials

  • Fu-Tong Liu, M.D., Ph.D.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2006

First Posted

September 1, 2006

Study Start

September 1, 2006

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

US(1)