Allergic Contact Dermatitis Clinical Trial
Official title:
Legs vs Back: Patient Experience and Quality of Patch Testing for Allergic Contact Dermatitis on Different Body Sites
NCT number | NCT06191627 |
Other study ID # | A23-305 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 4, 2024 |
Est. completion date | June 1, 2024 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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.) |
Country | Name | City | State |
---|---|---|---|
United States | Park Nicollet Contact Dermatitis Clinic | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
HealthPartners Institute |
United States,
Burkemper NM. Contact Dermatitis, Patch Testing, and Allergen Avoidance. Mo Med. 2015 Jul-Aug;112(4):296-300. — View Citation
Kimyon 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. — View Citation
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. — View Citation
Rodriguez-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. — View Citation
Wildemore 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Survey completed on day 3 of testing, taking no more than 10 minutes to complete. | |
Primary | 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. | Study coordinators will document the percentage of patches with appropriate occlusion on day 3 of testing prior to survey completion. | |
Secondary | 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. | Survey collected on day 5 |
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