Allergic Contact Dermatitis Clinical Trial
Official title:
Analysis of Immune Reactions Occurring Upon Administration of Patch Tests and Contact Dermatitis Affected Skin
NCT number | NCT01546298 |
Other study ID # | EGU-0757 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2012 |
Est. completion date | December 14, 2012 |
Verified date | June 2018 |
Source | Rockefeller University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study hopes to improve the investigators understanding of how the immune system acts in allergic contact dermatitis. In order to reach this goal, normal volunteers, who are suspected of having allergic contact dermatitis, will be patch tested for the fifteen most common allergens. Then, biopsies will be taken of the skin at the sites where the there is a positive reaction to the allergen. Also, small biopsies will be taken from an area that received a patch but no allergen and an area that did not receive a patch to serve as controls. In a second stage of the study, volunteers will receive patches with the allergen to which they demonstrated an allergic response. More biopsies will be taken, over three designated time points. The biopsied skin samples will then be studied in a laboratory.
Status | Completed |
Enrollment | 9 |
Est. completion date | December 14, 2012 |
Est. primary completion date | December 14, 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Male or non-pregnant, non-nursing female between 18 and 85 years of age - Able to give verbal and written informed consent - Must have a negative urine pregnancy test (for WOCBP). - Must be suspected by clinician of having ACD (history or self-report of signs of ACD as defined as eczematous rash development with fragrances, use of non-gold or silver jewelry, use of hair dye, cosmetics) and/or a relevant food allergy (one of the allergens we will be testing) Exclusion Criteria: Subjects taking any of the following systemic or topical therapies within 2 weeks of enrollment: corticosteroids, immunosuppressants, and/or any other medications that may affect the outcome of the study History of or suspected occupational allergies. Subjects who are nursing mothers or pregnant Hepatitis A, B, or C (self-reported) Subjects who have active localized or systemic medical conditions that, in the opinion of the investigator, would preclude or make unsafe their participation in the study Subjects who are unable to comply with study procedures, communicate effectively, cooperate with the investigator, or are unable to understand the study Subjects who have been treated with an investigational device or drug within 30 days of enrollment HIV positive as determined by self-reported history and/or a HIV POCT at screening History, physical, social or lab findings suggestive of any medical or psychological condition that would, in the opinion of the PI, make the candidate ineligible for the study Known anaphylactic reaction to food being tested in this study |
Country | Name | City | State |
---|---|---|---|
United States | The Rockefeller University | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Rockefeller University | Tel Aviv University, Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The response elicited by the allergen on relevant immune pathways as measured by cytokine levels in skin of IFN? (Th1 pathway), IL-13 (Th2 pathway), IL-9 (Th9 pathway), IL-17 (Th17 pathway) and IL-22 (Th22 pathway). | The response elicited by the allergen on relevant immune pathways as measured by cytokine levels in skin of IFN? (Th1 pathway), IL-13 (Th2 pathway), IL-9 (Th9 pathway), IL-17 (Th17 pathway) and IL-22 (Th22 pathway). | 5 weeks | |
Secondary | Skin samples will be analyzed by immunohistochemistry for various cell types. | Skin samples will be analyzed by immunohistochemistry for various cell types including several T cell subsets (CD4+ vs CD8+ and Foxp3+ subsets), dendritic cells, natural killer cells, macrophages, B cells, and neutrophils. Expression of cytokine mRNAs in these samples will be used to assess Th1 (interferon-gamma), Th2 (IL-4, IL-13),Th17 (IL-17), and Th22 (IL-22) T cell activation. | Day 2 and Day 7 |
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