UrticariaNCT00868036
Evaluating for Contact Allergies in Patients With Chronic Urticaria
An observational study of Urticaria and Patch Testing, run by Tufts Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urticaria, Patch Testing, Dermatitis
- What is being tested?
- Patch Testing
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Due to PI moving locations, information not available.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts Medical Center, Department of Dermatology
Boston, Massachusetts, 02111
About this study
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.
Read the 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.
- Conditions
- Urticaria, Patch Testing, Dermatitis, Allergy, Contact Sensitization
- Being tested
- Patch Testing
- Keywords
- urticaria, hives, dermatitis, rash, contact dermatitis, contact, contact sensitization, allergy, allergen, patch testing, IgG, delayed-hypersensitivity reaction, hypersensitivity
- Medical subject headings
- Urticaria, Dermatitis, Hypersensitivity, Exanthema, Dermatitis, Contact, Hypersensitivity, Delayed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patch TestingProcedure or surgery
Also called North American Contact Dermatitis Group (NACDG)
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.
| Study group | Role | What they receive |
|---|---|---|
| Patch testing | Patch testing on patients with chronic idiopathic dermatitis. Receives: Procedure: Patch Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1-3 months after patch testing performed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Contact Dermatitis Society (ACDS)
- Responsible party
- Sponsor
- Investigators
- Pamela Scheinman, M.D., Principal investigator, Tufts Medical Center, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868036
- Sponsor's protocol ID
- Contact Urticaria
- Other IDs
- IRB #8343, ACDS
- Status last verified
- Sep 2019
- First submitted
- 23 Mar 2009
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17190624Wai 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.
PubMed 12221863
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contact Allergens Causing Chronic Urticaria in a New England-Area Population
- ClinicalTrials.gov ID
- NCT00868036
- Acronym / sponsor ID
- Contact Urticaria
- Conditions
- Urticaria, Patch Testing, Dermatitis, Allergy, Contact Sensitization
- Keywords
- urticaria, hives, dermatitis, rash, contact dermatitis, contact, contact sensitization, allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- American Contact Dermatitis Society (ACDS)
- Study start
- Dec 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 24 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patch testing | – | Procedure: Patch TestingPatch testing on patients with chronic idiopathic dermatitis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Due to PI moving locations, information not available.
Key inclusion criteria (5 listed)
- Patients must have a documented diagnosis of chronic urticaria, which is defined as:
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patch TestingAlso: North American Contact Dermatitis Group (NACDG)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. | Procedure or surgery | Patch testing |
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Background: PubMed 17190624Guerra 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.
- Background: PubMed 12221863Wai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Scheinman, M.D. principal investigator
Tufts Medical Center, Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urticaria and Patch Testing, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Late read: three days after allergens for patch testing are placed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00868036, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.