Open, prospective, multi-center study to evaluate the bioequivalence of povidone (PVP) formulations of 2 T.R.U.E. TEST allergens: fragrance mix and thimerosal.
Bioequivalence will be determined in 40 adult subjects (20 per allergen), who have a clinical history of contact dermatitis and have tested positive to fragrance mix or thimerosal.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
* Thimerosal, 0.008 mg/cm2 in hydroxypropylcellulose * Thimerosal, 0.008 mg/cm2 in polyvinylpyrrolidone * Fragrance mix, 0.43 mg/cm2 in hydroxypropylcellulose with β-cyclodextrin * Fragrance mix, 0.43 mg/cm2 in polyvinylpyrrolidone with β-cyclodextrin Patches are placed at day one and removed 48 hours. The duration of the study lasts 21 days. However, the subject is only exposed the the study allergen for 48 hours.
River City Dermatology
Little Rock, Arkansas, United States
American Dermatology Associates
Shawnee Mission, Kansas, United States
Dermatology Specialists PSC
Louisville, Kentucky, United States
Winthrop University Hospital
Mineola, New York, United States
Analysis of Bioequivalence: Concordance
Percent agreement between T.R.U.E. Test allergen in PVP vs HPC is based on a positive test response during at least one post application visit
Time frame: Up to 21 days
Agreement Between TRUE Test Allergen and Reference Allergen
Sensitivity: Agreement between positive results for the test and reference allergen Specificity: Agreement between negative results for the test and reference allergen
Time frame: Up to 21 days
Irritation, Adhesion, Itching/Burning
Frequency of tape-induced irritation at the test site, incomplete panel adhesion and subject-reported sensations of itching or burning.
Time frame: Visit 2: 48 hours after patch application
Frequency of Late and Persistent Reactions
Late reactions occur 7-10 days after patch application Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application
Time frame: Day 2 (48 hours after application) through Day 21
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