Metal allergen patch test study.
A single application of an investigational patch test panel containing 11 hydrogel metal allergens and a corresponding patch test panel containing 11 petrolatum metal allergens will be applied to the upper back of human subjects to test diagnostic efficacy and safety. Patch test panels will be removed after being worn for approximately 48 hours. Study will require 6 visits over the course of 21 days; patch application, patch removal and 4 patch test site evaluation visits at days 4, 7, 14 and 21.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
Diagnostic patch test
DS Research
Louisville, Kentucky, United States
RECRUITINGNumber of participants with positive, negative, irritant or doubtful patch test responses and concordance between hydrogel and petrolatum allergens
Number of patch test responses will be recorded, concordance between hydrogel and petrolatum allergens will be measured
Time frame: Days 3-21
Evaluation of panel adhesion at visit 2 prior to panel removal
Number of subjects with excellent, good, poor or detached adhesion at panel removal
Time frame: Day 2
Evaluation of subject reported itching associated with test panels at visit 2 following panel removal
Number of subjects with no (none) weak, moderate or strong itching associated with test panels following panel removal
Time frame: Day 2
Evaluation of subject reported burning associated with test panels at visit 2 following panel removal.
Number of subjects with no (none) weak, moderate or strong burning associated with test panels following panel removal
Time frame: Day 2
Evaluation of tape irritation
Number of subjects with no (none) irritant or allergic tape irritation. Tape irritation is assessed at all visits. Investigator makes overall determination on day 21.
Time frame: Day 21
Evaluation of chip irritation
Number of subjects with no (none) irritant or allergic chip irritation. Chip irritation is assessed at all visits. Investigator makes overall determination on day 21.
Time frame: Day 21
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