Recruiting

Patch Testing vs. Patch Testing

Sponsor:

HealthPartners Institute

Code:

NCT06191627

Conditions

Allergic Contact Dermatitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Patch testing

Study Details

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

Study ID

NCT06191627

Start date

Mar 27, 2024

Status verified date

Dec, 2023

Completion date

Aug 30, 2024

Anticipated

Primary completion date

Aug 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Patch testing on the legs

Patches to be applied on the legs

active comparator: Patch testing on the back

Patches to be applied on the back

Interventions

Patch testing

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.

Primary outcome measure

  • Comfort during patch testing [ Time Frame: Survey completed on day 3 of testing, taking no more than 10 minutes to complete. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Caroline J Brumley, BS

9205394416caroline.brumley@parknicollet.com

Puneet Arora, BS

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

Locations

Park Nicollet Contact Dermatitis Clinic

Recruiting

Minneapolis, Minnesota, United States, 55450

Contacts

Sara Hylwa, MD

952-977-3450sara.hylwa@parknicollet.com

More Information

Sponsor

HealthPartners Institute

Last update posted

Aug 30, 2024

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by HealthPartners Institute on 2024-08-30.