Evaluating for Contact Allergies in Patients With Chronic Urticaria

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Tufts Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
American Contact Dermatitis Society (ACDS)
Information provided by:
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00868036
First received: March 23, 2009
Last updated: February 1, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention
Urticaria
Patch Testing
Dermatitis
Allergy
Contact Sensitization
Procedure: Patch Testing

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Contact Allergens Causing Chronic Urticaria in a New England-Area Population

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • To identify contact allergens with patch testing in patients with chronic idiopathic urticaria living in the New England area. [ Time Frame: Late read: three days after allergens for patch testing are placed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if avoidance of contact allergens causes the resolution of chronic urticaria in those patients with positive patch test results. [ Time Frame: 1-3 months after patch testing performed. ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2008
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Patch testing
Patch testing on patients with chronic idiopathic dermatitis.
Procedure: Patch Testing

Patch testing will be performed with a modified North American Contact Dermatitis Group (NACDG) standard series, cosmetics/preservative, fragrance, and textile series in all patients. Based on patient history, other appropriate allergen series will be added. After two days, patches will be removed and the areas will be inspected for type IV hypersensitivity reactions including papules, edema or vesicles.

Results will be graded and interpreted at a "delayed read," 3-4 days after allergens are placed with patch testing.

Other Name: North American Contact Dermatitis Group (NACDG)

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868036

Contacts
Contact: Nicole Dumont 617-636-7462 ndonovan1@tuftsmedicalcenter.org
Contact: Pamela Scheinman, M.D. 617-636-5235 pscheinman@tuftsmedicalcenter.org

Locations
United States, Massachusetts
Tufts Medical Center, Department of Dermatology Recruiting
Boston, Massachusetts, United States, 02111
Contact: Joseph Kerbleski, M.D.    617-636-7411    jkerbleski@tuftsmedicalcenter.org   
Principal Investigator: Pamela Scheinman, M.D.         
Sub-Investigator: Joseph Kerbleski, M.D.         
Sub-Investigator: Patrice Stewart, R.N.         
Sponsors and Collaborators
Tufts Medical Center
American Contact Dermatitis Society (ACDS)
Investigators
Principal Investigator: Pamela Scheinman, M.D. Tufts Medical Center, Department of Dermatology
  More Information

Publications:
Responsible Party: Pamela Scheinman, MD, Tufts Medical Center, Department of Dermatology
ClinicalTrials.gov Identifier: NCT00868036     History of Changes
Other Study ID Numbers: Contact Urticaria, IRB #8343
Study First Received: March 23, 2009
Last Updated: February 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts Medical Center:
urticaria
hives
dermatitis
rash
contact dermatitis
contact
contact sensitization
allergy
allergen
patch testing
IgG
delayed-hypersensitivity reaction
hypersensitivity

Additional relevant MeSH terms:
Dermatitis
Hypersensitivity
Urticaria
Skin Diseases
Immune System Diseases
Skin Diseases, Vascular
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on October 19, 2014