Patient Experience and Quality of Patch Testing on the Legs vs Back

NCT06191627 | Unknown

• 1 other identifier: A23-305
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Allergic Contact Dermatitis

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• Qualitative Survey Feedback

  Survey collected on day 5

Study Arms (2)

Patch testing on the legs

ACTIVE COMPARATOR

Patches to be applied on the legs

Diagnostic Test: Patch testing

Patch testing on the back

ACTIVE COMPARATOR

Patches to be applied on the back

Diagnostic Test: Patch testing

Interventions

Patch testing DIAGNOSTIC_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.

Patch testing on the back; Patch testing on the legs

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

Park Nicollet Contact Dermatitis Clinic

Minneapolis, Minnesota, 55450, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 31757238 RESULT

• 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.

  PMID: 12894072 RESULT

• Burkemper NM. Contact Dermatitis, Patch Testing, and Allergen Avoidance. Mo Med. 2015 Jul-Aug;112(4):296-300.

  PMID: 26455061 RESULT

• 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.

  PMID: 33273240 RESULT

• 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.

  PMID: 30179972 RESULT

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Sara Hylwa, MD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline J Brumley, BS

CONTACT

9205394416; caroline.brumley@parknicollet.com

Puneet Arora, BS

CONTACT

952-463-5068; puneet.arora@parknicollet.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: March 27, 2024
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: August 30, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)