Allergic Contact DermatitisNCT06191627
Patient Experience and Quality of Patch Testing on the Legs vs Back
A study testing Patch testing in people with Allergic Contact Dermatitis, run by HealthPartners Institute at 1 site in United States.
Trial summary
The gold standard for the diagnosis of allergic contact dermatitis is patch testing, during which allergens are affixed to the skin underneath tape and left for multiple days. A large area of clear skin is thus required for successful testing. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Allergic Contact Dermatitis
- What is being tested?
- Patch testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2024to 30 Aug 2024
- Phase
- Interventional
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Undergoing patch testing at Park Nicollet Contact Dermatitis
- At least 90 patches applied at one time, representing comprehensive testing rather than limited testing with few patches that may skew results
- Both back and thighs adequate for patch testing (see exclusion criteria below)
Who cannot join
- Patient is 17 or younger
- Patient is pregnant or breastfeeding
- Specialized patch testing with low number of patches (less than 90)
- Rash that would preclude testing on thighs or back
- Large tattoos that would preclude testing on thighs or back
- Limited space on thighs or back due to body habitus
- Patient has specific needs necessitating use of the thighs or back (event, breastfeeding, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Park Nicollet Contact Dermatitis Clinic
Minneapolis, Minnesota, 55450
Sara Hylwa, MD, 952-977-3450, sara.hylwa@parknicollet.com
About this study
Official title: Legs vs Back: Patient Experience and Quality of Patch Testing for Allergic Contact Dermatitis on Different Body Sites
The gold standard for the diagnosis of allergic contact dermatitis is patch testing, during which allergens are affixed to the skin underneath tape and left for multiple days. A large area of clear skin is thus required for successful testing.
While the back is traditionally thought to be the ideal area for testing, the thighs may be more available or advantageous. This study seeks to randomize patients undergoing patch testing to have patches placed on the back or the thighs. The investigators seek to understand the benefits of testing on the legs versus the back in terms of patient experience as well as achieving a successful test. This study will measure patient experience using a survey administered to patients. Quality of testing will be assessed by study coordinators prior the removal of patches.
Read the detailed description
Background:
Patch testing for ACD is a rigorous process. While the patches are on the patient's skin, they must be careful not to perform movements that will cause the tape to detach, thus compromising the integrity of the test. The classical placement of patches is on the back due to: a) the large body surface area in which to place the patches, b) the generally flat surface which allows for adequate adhesion of the patches (as opposed to a more rounded body surface), and c) the difficulty for patients to manipulate the area, thus limiting patient interference with the testing site and ensuring the tape remains adhered. The primary disadvantages of placing patches on one's back are the physical limitations, e.g the inability to raise one's arms above shoulder level, bend, twist, or reach. This has both comfort and practical disadvantages as patients find it hard to drive, clothe, and perform their activities of daily living (ADLs). These limitations improve the quality of the testing, but it is reasonable to think that some discomfort could be prevented, as an element of the physical limitations result from pulling or tugging due to the copious amounts of tape applied to achieve complete occlusion. For patients who are parents or caregivers, or those who are unable to take off of work during the week, these limitations can prove to be an immense challenge. Breastfeeding mothers may be unable to comfortably feed their infants. Patients also report increased pain, sleeping difficulties, and worsening of rash during patch testing.
Thus, the investigators seek to investigate further patient comfort during patch testing to improve the patient experience. The thighs have been used in our clinic as a patch testing as an alternative to the back, either when the back has rash, tattoos, or too small an area for complete patch testing. Anecdotal evidence suggests that the thighs may provide a more pleasant patch testing experience with decreased restrictions in mobility. In our experience, no limitation has been seen in terms of the quality of the patches with placement on the thighs. To date, there has been little published literature regarding the ideal location of patch testing, either in respect to patient experience or quality of testing. One study has proposed alternatives to the tape used to adhere patches in an effort to improve comfort. Another study examined retrospective data to identify rates of symptoms during patch testing (pain, sleep difficulty, need for medication, site itching or itching elsewhere, and worsening rash) and their correlation with patch location. Various significant statistical associations were found, such as highest levels of pain with placement on the arms and increased need for medication and location on the chest. However, more information is needed comparing specifically the legs and the back, the two most commonly tested areas, in terms of patient comfort and quality of the test. Additionally, by obtaining a more holistic understanding of patient comfort, the investigators will be able to derive a more useful and clinically applicable answer as to whether the legs or back is preferable for testing location.
Sample Size:
Sample size will be determined using a pragmatic approach based on time constraints and size of recruitment pool. Because there exists no previously validated instrument to measure patient experience during patch testing (or something similar), the investigators will be developing our own survey. The survey will document important demographic information and assess patient experience during patch testing using agreements questions that will be compared between both groups. HealthPartners Center for Evaluation and Survey Research (CESR) will help to develop an effective instrument. 30 patients will be enrolled per treatment group. Between 10-20 patients are seen per week on average, and the investigators estimate that 20% will not meet inclusion criteria. Assuming that 50% of patients who meet enrollment criteria will agree to take part in the study, data collection will take between 8-15 weeks. 100% study follow through should be attainable, as it is very rare for patients who begin patch testing to be lost to follow-up.
- Conditions
- Allergic Contact Dermatitis
- Being tested
- Patch testing
- Medical subject headings
- Dermatitis, Allergic Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patch testingDiagnostic test
Unlike many different dermatological diseases, a biopsy cannot easily distinguish ACD from irritant contact dermatitis or other forms of chronic dermatitis. Thus, the gold standard for diagnosis is patch testing. During patch testing, allergens are placed on the skin under occlusion using an aluminum disc and tape. When undergoing intensive testing for ACD, as many as 300 patches may be applied to a patient. Therefore, a large area of skin clear of rash is required, most often the back, but patches are frequently applied to the legs as well. Patches are applied by clinic patch technicians. They will proceed with their normal procedures, following the randomization to apply the patches to the appropriate location. Patches will be applied to the skin once, as is the normal standard of care. Patches are applied on day 1 and removed on day 3. Patients continue testing through day 5, though study elements will cease on day 3.
| Study group | Role | What they receive |
|---|---|---|
| Patch testing on the legs | Active comparator | Patches to be applied on the legs Receives: Diagnostic Test: Patch testing |
| Patch testing on the back | Active comparator | Patches to be applied on the back Receives: Diagnostic Test: Patch testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort during patch testing
Patients in both arms will complete a survey that assesses their comfort while wearing patches as part of patch testing. The survey will be the same for both arms of the study. The primary outcome will consist of level of agreement with statements.
Measured: Survey completed on day 3 of testing, taking no more than 10 minutes to complete.
Quality of patch testing
The quality of patch testing in both arms will also be assessed. This will be based on the percentage of patches with appropriate occlusion. This will be defined by the presence of indentation made by the aluminum discs used for patching.
Measured: Study coordinators will document the percentage of patches with appropriate occlusion on day 3 of testing prior to survey completion.
Secondary outcomes (1)
Qualitative Survey Feedback
Participants in both study arms will be able to leave qualitative feedback at the end of their survey. Any qualitative feedback left will be compared between both study arms.
Measured: Survey collected on day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start27 Mar 2024
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Allergic Contact DermatitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a two-armed randomized trial. Patients will be recruited from the cohort already undergoing patch testing at our clinic. Enrolled and consented patients will be randomized in a 1:1 ratio to the legs or back study arm via a predetermined randomization order. Patches will be placed as indicated per each patient case, either on the thighs or back. At the 48-hr time point, patches will be removed. Study coordinators will grade success of testing by noting total patches applied and counting patches with a complete circular indentation, partial indentation, or absent indentation from the Finn chambers. Patients will then complete a survey prior to interpretation of their testing by the physician. The predetermined randomization order and survey data will be stored in the secure PN server.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Hylwa, MD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191627
- Sponsor's protocol ID
- A23-305
- Status last verified
- Dec 2023
- First submitted
- 20 Dec 2023
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nassau S, Fonacier L. Allergic Contact Dermatitis. Med Clin North Am. 2020 Jan;104(1):61-76. doi: 10.1016/j.mcna.2019.08.012. Epub 2019 Oct 28.
PubMed 31757238Wildemore JK, Junkins-Hopkins JM, James WD. Evaluation of the histologic characteristics of patch test confirmed allergic contact dermatitis. J Am Acad Dermatol. 2003 Aug;49(2):243-8. doi: 10.1067/s0190-9622(03)00865-x.
PubMed 12894072Burkemper NM. Contact Dermatitis, Patch Testing, and Allergen Avoidance. Mo Med. 2015 Jul-Aug;112(4):296-300.
PubMed 26455061Kimyon RS, Hylwa SA, Neeley AB, Warshaw EM. Patch Testing: The Patient Experience. Dermatitis. 2021 Sep-Oct 01;32(5):333-338. doi: 10.1097/DER.0000000000000656.
PubMed 33273240Rodriguez-Lomba E, Sanchez-Herrero A, Morales P, Suarez-Fernandez R. Transparent Film Dressings for Patch Testing Leads to Better Adhesion and Patient Comfort. Dermatitis. 2018 Sep/Oct;29(5):289. doi: 10.1097/DER.0000000000000398. No abstract available.
PubMed 30179972
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Legs vs Back: Patient Experience and Quality of Patch Testing for Allergic Contact Dermatitis on Different Body Sites
- ClinicalTrials.gov ID
- NCT06191627
- Acronym / sponsor ID
- A23-305
- Conditions
- Allergic Contact Dermatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 5 Jan 2024 (actual)
- 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.
The gold standard for the diagnosis of allergic contact dermatitis is patch testing, during which allergens are affixed to the skin underneath tape and left for multiple days. A large area of clear skin is thus required for successful testing.
While the back is traditionally thought to be the ideal area for testing, the thighs may be more available or advantageous. This study seeks to randomize patients undergoing patch testing to have patches placed on the back or the thighs. The investigators seek to understand the benefits of testing on the legs versus the back in terms of patient experience as well as achieving a successful test. This study will measure patient experience using a survey administered to patients. Quality of testing will be assessed by study coordinators prior the removal of patches.
Detailed description
Background:
Patch testing for ACD is a rigorous process. While the patches are on the patient's skin, they must be careful not to perform movements that will cause the tape to detach, thus compromising the integrity of the test. The classical placement of patches is on the back due to: a) the large body surface area in which to place the patches, b) the generally flat surface which allows for adequate adhesion of the patches (as opposed to a more rounded body surface), and c) the difficulty for patients to manipulate the area, thus limiting patient interference with the testing site and ensuring the tape remains adhered. The primary disadvantages of placing patches on one's back are the physical limitations, e.g the inability to raise one's arms above shoulder level, bend, twist, or reach. This has both comfort and practical disadvantages as patients find it hard to drive, clothe, and perform their activities of daily living (ADLs). These limitations improve the quality of the testing, but it is reasonable to think that some discomfort could be prevented, as an element of the physical limitations result from pulling or tugging due to the copious amounts of tape applied to achieve complete occlusion. For patients who are parents or caregivers, or those who are unable to take off of work during the week, these limitations can prove to be an immense challenge. Breastfeeding mothers may be unable to comfortably feed their infants. Patients also report increased pain, sleeping difficulties, and worsening of rash during patch testing.
Thus, the investigators seek to investigate further patient comfort during patch testing to improve the patient experience. The thighs have been used in our clinic as a patch testing as an alternative to the back, either when the back has rash, tattoos, or too small an area for complete patch testing. Anecdotal evidence suggests that the thighs may provide a more pleasant patch testing experience with decreased restrictions in mobility. In our experience, no limitation has been seen in terms of the quality of the patches with placement on the thighs. To date, there has been little published literature regarding the ideal location of patch testing, either in respect to patient experience or quality of testing. One study has proposed alternatives to the tape used to adhere patches in an effort to improve comfort. Another study examined retrospective data to identify rates of symptoms during patch testing (pain, sleep difficulty, need for medication, site itching or itching elsewhere, and worsening rash) and their correlation with patch location. Various significant statistical associations were found, such as highest levels of pain with placement on the arms and increased need for medication and location on the chest. However, more information is needed comparing specifically the legs and the back, the two most commonly tested areas, in terms of patient comfort and quality of the test. Additionally, by obtaining a more holistic understanding of patient comfort, the investigators will be able to derive a more useful and clinically applicable answer as to whether the legs or back is preferable for testing location.
Sample Size:
Sample size will be determined using a pragmatic approach based on time constraints and size of recruitment pool. Because there exists no previously validated instrument to measure patient experience during patch testing (or something similar), the investigators will be developing our own survey. The survey will document important demographic information and assess patient experience during patch testing using agreements questions that will be compared between both groups. HealthPartners Center for Evaluation and Survey Research (CESR) will help to develop an effective instrument. 30 patients will be enrolled per treatment group. Between 10-20 patients are seen per week on average, and the investigators estimate that 20% will not meet inclusion criteria. Assuming that 50% of patients who meet enrollment criteria will agree to take part in the study, data collection will take between 8-15 weeks. 100% study follow through should be attainable, as it is very rare for patients who begin patch testing to be lost to follow-up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a two-armed randomized trial. Patients will be recruited from the cohort already undergoing patch testing at our clinic. Enrolled and consented patients will be randomized in a 1:1 ratio to the legs or back study arm via a predetermined randomization order. Patches will be placed as indicated per each patient case, either on the thighs or back. At the 48-hr time point, patches will be removed. Study coordinators will grade success of testing by noting total patches applied and counting patches with a complete circular indentation, partial indentation, or absent indentation from the Finn chambers. Patients will then complete a survey prior to interpretation of their testing by the physician. The predetermined randomization order and survey data will be stored in the secure PN server.
| Arm | Type | Receives |
|---|---|---|
| Patch testing on the legs | Active comparator | Diagnostic Test: Patch testingPatches to be applied on the legs |
| Patch testing on the back | Active comparator | Diagnostic Test: Patch testingPatches to be applied on the back |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older
- Undergoing patch testing at Park Nicollet Contact Dermatitis
- At least 90 patches applied at one time, representing comprehensive testing rather than limited testing with few patches that may skew results
- Both back and thighs adequate for patch testing (see exclusion criteria below)
Key exclusion criteria (7 listed)
- Patient is 17 or younger
- Patient is pregnant or breastfeeding
- Specialized patch testing with low number of patches (less than 90)
- Rash that would preclude testing on thighs or back
- Large tattoos that would preclude testing on thighs or back
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 testingUnlike many different dermatological diseases, a biopsy cannot easily distinguish ACD from irritant contact dermatitis or other forms of chronic dermatitis. Thus, the gold standard for diagnosis is patch testing. During patch testing, allergens are placed on the skin under occlusion using an aluminum disc and tape. When undergoing intensive testing for ACD, as many as 300 patches may be applied to a patient. Therefore, a large area of skin clear of rash is required, most often the back, but patches are frequently applied to the legs as well. Patches are applied by clinic patch technicians. They will proceed with their normal procedures, following the randomization to apply the patches to the appropriate location. Patches will be applied to the skin once, as is the normal standard of care. Patches are applied on day 1 and removed on day 3. Patients continue testing through day 5, though study elements will cease on day 3. | Diagnostic test | Patch testing on the back, Patch testing on the legs |
Primary outcome
Comfort during patch testing
Time frame: Survey completed on day 3 of testing, taking no more than 10 minutes to complete.
Patients in both arms will complete a survey that assesses their comfort while wearing patches as part of patch testing. The survey will be the same for both arms of the study. The primary outcome will consist of level of agreement with statements.
Quality of patch testing
Time frame: Study coordinators will document the percentage of patches with appropriate occlusion on day 3 of testing prior to survey completion.
The quality of patch testing in both arms will also be assessed. This will be based on the percentage of patches with appropriate occlusion. This will be defined by the presence of indentation made by the aluminum discs used for patching.
1 secondary outcome
Qualitative Survey Feedback
Time frame: Survey collected on day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Results publication: PubMed 31757238Nassau S, Fonacier L. Allergic Contact Dermatitis. Med Clin North Am. 2020 Jan;104(1):61-76. doi: 10.1016/j.mcna.2019.08.012. Epub 2019 Oct 28.
- Results publication: PubMed 12894072Wildemore JK, Junkins-Hopkins JM, James WD. Evaluation of the histologic characteristics of patch test confirmed allergic contact dermatitis. J Am Acad Dermatol. 2003 Aug;49(2):243-8. doi: 10.1067/s0190-9622(03)00865-x.
- Results publication: PubMed 26455061Burkemper NM. Contact Dermatitis, Patch Testing, and Allergen Avoidance. Mo Med. 2015 Jul-Aug;112(4):296-300.
- Results publication: PubMed 33273240Kimyon RS, Hylwa SA, Neeley AB, Warshaw EM. Patch Testing: The Patient Experience. Dermatitis. 2021 Sep-Oct 01;32(5):333-338. doi: 10.1097/DER.0000000000000656.
- Results publication: PubMed 30179972Rodriguez-Lomba E, Sanchez-Herrero A, Morales P, Suarez-Fernandez R. Transparent Film Dressings for Patch Testing Leads to Better Adhesion and Patient Comfort. Dermatitis. 2018 Sep/Oct;29(5):289. doi: 10.1097/DER.0000000000000398. No abstract available.
- Individual participant dataSharing planned: No
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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.
Sara Hylwa, MD principal investigator
HealthPartners Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patch testing in people with Allergic Contact Dermatitis, run by HealthPartners Institute 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 30 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline J Brumley, BS (9205394416, caroline.brumley@parknicollet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort during patch testing (time frame: Survey completed on day 3 of testing, taking no more than 10 minutes to complete.). The study lists 2 primary outcomes in all. 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 NCT06191627, which also lists 5 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 30 Aug 2024.