Evaluating for Contact Allergies in Patients With Chronic Urticaria

NCT00868036 | Completed

• 3 other identifiers: Contact UrticariaIRB #8343ACDS
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Late read: three days after allergens for patch testing are placed

Secondary Outcomes (1)

• 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.

  1-3 months after patch testing performed.

Study Arms (1)

Patch testing

Patch testing on patients with chronic idiopathic dermatitis.

Procedure: Patch Testing

Interventions

Patch Testing PROCEDURE

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.

Also known as: North American Contact Dermatitis Group (NACDG)

Patch testing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Study Population

Due to PI moving locations, information not available.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts Medical Center: lead
• American Contact Dermatitis Society (ACDS): collaborator

Study Sites (1)

Tufts Medical Center, Department of Dermatology

Boston, Massachusetts, 02111, United States

Location

Related Publications (2)

• 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.

  PMID: 17190624 BACKGROUND

• 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.

  PMID: 12221863 BACKGROUND

MeSH Terms

Conditions

Urticaria; Dermatitis; Hypersensitivity; Exanthema; Dermatitis, Contact; Hypersensitivity, Delayed

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Immune System Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Pamela Scheinman, M.D.

  Tufts Medical Center, Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 24, 2009
• Study Start: December 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: September 11, 2019

Record last verified: 2019-09

Locations

US (1)