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Immune Reactions in Contact Dermatitis Affected Skin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01546298
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : June 20, 2018
Sponsor:
Collaborators:
Washington University School of Medicine
Tel Aviv University
Information provided by (Responsible Party):
Rockefeller University

Tracking Information
First Submitted Date March 2, 2012
First Posted Date March 7, 2012
Last Update Posted Date June 20, 2018
Actual Study Start Date January 2012
Actual Primary Completion Date December 14, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 6, 2017)
The response elicited by the allergen on relevant immune pathways as measured by cytokine levels in skin of IFNγ (Th1 pathway), IL-13 (Th2 pathway), IL-9 (Th9 pathway), IL-17 (Th17 pathway) and IL-22 (Th22 pathway). [ Time Frame: 5 weeks ]
The response elicited by the allergen on relevant immune pathways as measured by cytokine levels in skin of IFNγ (Th1 pathway), IL-13 (Th2 pathway), IL-9 (Th9 pathway), IL-17 (Th17 pathway) and IL-22 (Th22 pathway).
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: June 18, 2018)
Skin samples will be analyzed by immunohistochemistry for various cell types. [ Time Frame: Day 2 and Day 7 ]
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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Immune Reactions in Contact Dermatitis Affected Skin
Official Title Analysis of Immune Reactions Occurring Upon Administration of Patch Tests and Contact Dermatitis Affected Skin
Brief Summary 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.
Detailed Description

Allergic contact dermatitis is a term for a skin reaction resulting from exposure to specific substances that come into contact with skin that is hypersensitive (allergic) to the substance. These substances are called "allergens." Some common allergens are nickel, rubber, dyes, poison ivy, poison oak and other related plants. These allergens do not cause a skin reaction in most individuals, but for some, once the skin becomes sensitive or allergic to the substance, any exposure to that specific allergen will produce a rash that may consist of redness, swelling and blisters. This rash may become worse with each exposure to the allergen. The skin reaction results from two phases. In the induction phase, initial exposure to the allergen occurs. The body recognizes the allergen as foreign and the immune system, which is the body's primary line of defense against infections and other things perceived as foreign to the body, mounts an immune response against the body, itself. During this immune response, cells specific to the allergen are activated. In the second phase, the elicitation phase, the skin is again exposed to the allergen and an immune response occurs, as the cells that are specific to the allergen attack the skin, leading to the rash. In order to diagnose allergic contact dermatitis, a clinician will discuss the materials that touch the patient's skin at work and home and perform patch tests. In a patch test, a very small amount of the suspected allergens are applied to the skin for a fixed time. After that designated time, the clinician will determine whether a reaction has occurred to the applied allergens. Currently, the main treatment for allergic contact dermatitis is avoidance of the allergen.

This study hopes to improve our 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 by methods such as immunohistochemistry and microarray analysis, which will help define the progression of the immune reaction in allergic contact dermatitis. The rationale for the study is to better understand how the immune system is activated to produce the rash of allergic contact dermatitis, so that treatments can target the cells that are involved in the activation.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Patch tests of skin
Sampling Method Non-Probability Sample
Study Population Allergic Contact Dermatitis
Condition Allergic Contact Dermatitis
Intervention Other: Patch tests
Patch tests for allergic reaction
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 18, 2018)
9
Original Estimated Enrollment
 (submitted: March 6, 2012)
500
Actual Study Completion Date December 14, 2012
Actual Primary Completion Date December 14, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01546298
Other Study ID Numbers EGU-0757
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Rockefeller University
Original Responsible Party Same as current
Current Study Sponsor Rockefeller University
Original Study Sponsor Same as current
Collaborators
  • Washington University School of Medicine
  • Tel Aviv University
Investigators
Principal Investigator: Emma Guttman, MD,PhD The Rockefeller University
PRS Account Rockefeller University
Verification Date June 2018