Immune Reactions in Contact Dermatitis Affected Skin

NCT01546298 | Completed

• 1 other identifier: EGU-0757
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Contact Dermatitis

Keywords

Contact Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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).

  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).

  5 weeks

Secondary Outcomes (1)

• Skin samples will be analyzed by immunohistochemistry for various cell types.

  Day 2 and Day 7

Interventions

Patch tests OTHER

Patch tests for allergic reaction

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Allergic Contact Dermatitis

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rockefeller University: lead
• Washington University School of Medicine: collaborator
• Tel Aviv University: collaborator

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patch tests of skin

MeSH Terms

Conditions

Dermatitis, Allergic Contact; Dermatitis, Contact

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Emma Guttman, MD,PhD

  The Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 7, 2012
• Study Start: January 1, 2012
• Primary Completion: December 14, 2012
• Study Completion: December 14, 2012
• Last Updated: June 20, 2018

Record last verified: 2018-06

Locations

US (1)