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History of Changes for Study: NCT01546298
Immune Reactions in Contact Dermatitis Affected Skin
Latest version (submitted June 18, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 6, 2012 None (earliest Version on record)
2 October 18, 2012 Study Status
3 May 16, 2013 Study Status and Contacts/Locations
4 December 20, 2013 Study Status
5 December 17, 2014 Study Status, Contacts/Locations, Outcome Measures and Oversight
6 August 11, 2015 Study Status
7 April 25, 2016 Recruitment Status, Study Status, Contacts/Locations and IPDSharing
8 June 6, 2017 Eligibility, Study Design, Study Status, Outcome Measures and Sponsor/Collaborators
9 June 18, 2018 Recruitment Status, Study Status, Study Design and Outcome Measures
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Study NCT01546298
Submitted Date:  March 6, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: EGU-0757
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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2012
Overall Status: Recruiting
Study Start: January 2012
Primary Completion: November 2026 [Anticipated]
Study Completion: November 2026 [Anticipated]
First Submitted: March 2, 2012
First Submitted that
Met QC Criteria:
March 6, 2012
First Posted: March 7, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 6, 2012
Last Update Posted: March 7, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Rockefeller University
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Allergic Contact Dermatitis
Keywords: Contact Dermatitis
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples Without DNA
Biospecimen Description: Patch tests of skin
Enrollment: 500 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Intervention Details:
Patch tests
Patch tests for allergic reaction
Open or close this module Outcome Measures
Open or close this module Eligibility
Study Population: Allergic Contact Dermatitis
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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
Open or close this module Contacts/Locations
Central Contact Person: Caroline Melendez
Telephone: 1-800-782-2737
Study Officials: Emma Guttman, MD,PhD
Principal Investigator
The Rockefeller University
Locations: United States, New York
The Rockefeller University
[Recruiting]
New York, New York, United States, 10065
Contact:Contact: Caroline Melendez 800-782-2737
Contact:Principal Investigator: Emma Guttman, MD,PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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