Clinical trial NCT00868036: Evaluating for Contact Allergies in Patients With Chronic Urticaria
Official title: Contact Allergens Causing Chronic Urticaria in a New England-Area Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urticaria
Patch Testing
Dermatitis
Allergy
Contact Sensitization
Keywords: urticaria
hives
dermatitis
rash
contact dermatitis
contact
contact sensitization
allergy
allergen
patch testing
IgG
delayed-hypersensitivity reaction
hypersensitivity
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: American Contact Dermatitis Society (ACDS)
First posted: 2009-03-24
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Study population: Due to PI moving locations, information not available.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients must have a documented diagnosis of chronic urticaria, which is defined as:

  * urticaria (hives), in which each individual lesion lasts less than 48 hours,
  * urticaria which occurs several times per week,
  * urticaria which has lasted in this manner for a minimum of 6 weeks.

Referring physicians will be asked to provide this documentation, and patients will be asked to confirm these characteristics. Patients should have already undergone a workup to exclude other causes of their urticaria, and if any abnormalities have been encountered, these abnormalities would need to be insufficient to explain the extent of their urticaria.

Exclusion Criteria:

* Those patients with an explanation for their chronic urticaria.
* Patients may have their test postponed if they are currently using topical steroids to the area to be tested, or are taking prednisone or its equivalent daily.

Due to PI moving locations, no additional information available.

Primary outcomes:
measure: PI changed location, no additional information available. To identify contact allergens with patch testing in patients with chronic idiopathic urticaria living in the New England area.
timeFrame: Late read: three days after allergens for patch testing are placed
Secondary outcomes:
measure: PI changed location, no additional information available. To determine if avoidance of contact allergens causes the resolution of chronic urticaria in those patients with positive patch test results.
timeFrame: 1-3 months after patch testing performed.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center, Department of Dermatology
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center, Department of Dermatology
name: Pamela Scheinman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guerra L, Rogkakou A, Massacane P, Gamalero C, Compalati E, Zanella C, Scordamaglia A, Canonica WG, Passalacqua G. Role of contact sensitization in chronic urticaria. J Am Acad Dermatol. 2007 Jan;56(1):88-90. doi: 10.1016/j.jaad.2006.07.023. Epub 2006 Oct 20.
citation: Wai YC, Sussman GL. Evaluating chronic urticaria patients for allergies, infections, or autoimmune disorders. Clin Rev Allergy Immunol. 2002 Oct;23(2):185-93. doi: 10.1385/CRIAI:23:2:185.