Immune Reactions in Contact Dermatitis Affected Skin

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Rockefeller University
Sponsor:
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT01546298
First received: March 2, 2012
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Allergic Contact Dermatitis
Other: Patch tests

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Immune Reactions Occurring Upon Administration of Patch Tests and Contact Dermatitis Affected Skin

Further study details as provided by Rockefeller University:

Biospecimen Retention:   Samples Without DNA

Patch tests of skin


Estimated Enrollment: 500
Study Start Date: January 2012
Estimated Study Completion Date: November 2026
Estimated Primary Completion Date: November 2026 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Patch tests
    Patch tests for allergic reaction
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Allergic Contact Dermatitis

Criteria

Inclusion Criteria:

  • Male or non-pregnant female between 18 and 60 years of age
  • Able to give verbal and written informed consent
  • Must have a negative urine pregnancy test (for WOCBP). For women of childbearing potential (WOCBP) willing to use an acceptable method of contraception to prevent pregnancy for the duration of the study. Acceptable forms of contraception are listed in section 16 of this application.
  • 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)

Exclusion Criteria:

  • Patients with suspected occupational allergies
  • 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
  • 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 nursing mothers, pregnant, or planning to become pregnant at anytime during the course of the study or within 30 days of study completion
  • 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 another 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 sensitivity to bandage or adhesive tape
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546298

Contacts
Contact: Caroline Melendez 1-800-782-2737

Locations
United States, New York
The Rockefeller University Recruiting
New York, New York, United States, 10065
Contact: Lauren Corregano    800-782-2737      
Principal Investigator: Emma Guttman, MD,PhD         
Sponsors and Collaborators
Rockefeller University
Investigators
Principal Investigator: Emma Guttman, MD,PhD The Rockefeller University
  More Information

No publications provided

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT01546298     History of Changes
Other Study ID Numbers: EGU-0757
Study First Received: March 2, 2012
Last Updated: December 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rockefeller University:
Contact Dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Contact
Dermatitis, Allergic Contact
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014