Allergy Clinical Trial
Official title:
Contact Allergens Causing Chronic Urticaria in a New England-Area Population
Hives affects 10-25% of the population worldwide at some time during their lifetime. Hives
are itchy transient swellings of the skin lasting 4-36 hours. Chronic urticaria is defined as
hives that have been ongoing for six weeks or more.
Patch testing is performed to diagnose allergic contact dermatitis, and if contact allergens
are found via patch testing, patients can often be cured of their dermatitis. However, patch
testing is currently not routinely performed in the evaluation of patients with chronic
idiopathic urticaria.
Our hypothesis is to see if contact allergens can be identified with patch testing in
patients with chronic urticaria, and, if any allergens are identified, to see if avoiding
these contact allergens will make the chronic urticaria go away.
Study Visits: Patients will be seen on Day #0, which will be a Monday, and the study will be
explained. If they agree to participate, consent will be signed and they will be interviewed
to determine any relevant occupational or personal exposures to potential allergens. They
will be examined to determine if they have sufficient normal skin to undergo patch testing.
Patients will be allowed to use antihistamines to treat pruritus as antihistamines do not
abrogate T-cell-mediated immune reactions.
Scanpor (paper) tape strips of 10 allergens each contained within 10-mm Finn (aluminum)
chambers will be applied to the patient's back. All patients will be tested to the Tufts
Medical Center standard series, fragrance, cosmetics/preservative, and textile series. Based
on patient history, other appropriate allergen series will be added.
After two days (on Day #2, a Wednesday), patches will be removed and the areas will be
inspected for type IV hypersensitivity reactions including papules, edema or vesicles. The
testing areas will be marked using a surgical marker and the patients will return the
following day (on Day #3, a Thursday) for a delayed reading.
Interpretation: Patch test reactions will be interpreted by using NACDG criteria: negative
reaction (macular erythema); 1+ (weak reaction; non-vesicular erythema, infiltration, and
possibly papules); 2+ (strong reaction; edematous or vesicular); 3+ (extreme reaction;
spreading, bullous, or ulcerative lesions), or irritant reaction. If contact allergens are
found, patients will be educated about allergen avoidance and given listings from the Contact
Allergen Replacement Database delineating products they may use which do not contain their
allergens.
Follow-up Interview: One to three months after patch testing, the patients will be contacted
to determine whether allergen avoidance has resulted in any improvement in their chronic
urticaria. They will be asked how well they have adhered to allergen avoidance (completely
avoided, mostly avoided, somewhat avoided, or not at all avoided) and how their urticaria has
been since changing their habits (a response score: completely resolved, mostly improved,
somewhat improved, no change, or worse).
Costs: there will be no costs to the patients to participate in this study. Patients will be
seen as regular patients at Tufts Medical Center, and their insurance providers will be
billed for the visits. A stipend will be provided to patients to cover the costs of their
transportation.
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