Immune Reactions in Contact Dermatitis Affected Skin

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.

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