search
Back to results

Evaluating for Contact Allergies in Patients With Chronic Urticaria

Primary Purpose

Urticaria, Patch Testing, Dermatitis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Patch Testing
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Urticaria focused on measuring urticaria, hives, dermatitis, rash, contact dermatitis, contact, contact sensitization, allergy, allergen, patch testing, IgG, delayed-hypersensitivity reaction, hypersensitivity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tufts Medical Center, Department of Dermatology

Arms of the Study

Arm 1

Arm Type

Arm Label

Patch testing

Arm Description

Patch testing on patients with chronic idiopathic dermatitis.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 23, 2009
Last Updated
September 6, 2019
Sponsor
Tufts Medical Center
Collaborators
American Contact Dermatitis Society (ACDS)
search

1. Study Identification

Unique Protocol Identification Number
NCT00868036
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
American Contact Dermatitis Society (ACDS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patch testing
Arm Description
Patch testing on patients with chronic idiopathic dermatitis.
Intervention Type
Procedure
Intervention Name(s)
Patch Testing
Other Intervention Name(s)
North American Contact Dermatitis Group (NACDG)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
Late read: three days after allergens for patch testing are placed
Secondary Outcome Measure Information:
Title
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.
Time Frame
1-3 months after patch testing performed.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Study Population Description
Due to PI moving locations, information not available.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Scheinman, M.D.
Organizational Affiliation
Tufts Medical Center, Department of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center, Department of Dermatology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17190624
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.
Results Reference
background
PubMed Identifier
12221863
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.
Results Reference
background

Learn more about this trial

Evaluating for Contact Allergies in Patients With Chronic Urticaria

We'll reach out to this number within 24 hrs