We propose a prospective, multi-center, double-blind, randomized study comparing the diagnostic performance (primary) and safety (secondary) of 3 concentrations of Disperse blue 106 and 4 concentrations of Bronopol in 40 adult subjects (20 subjects per allergen) with a clinical history of contact dermatitis and a positive patch test (current or previous) to the corresponding reference petrolatum allergen ("sensitives").
Primary endpoint: To evaluate the diagnostic performance of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include: * Determination of the lowest concentration eliciting positive skin reactions (+1 or +2) in 70-90% of sensitive subjects. * Frequency of positive, negative, doubtful and irritant reactions for each allergen and tested concentration. * Concordance/discordance as compared to the corresponding reference petrolatum allergen. Secondary endpoint: To evaluate the safety of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include: * The frequency of tape-induced irritation at the test site, incomplete panel adhesion, and subject-reported sensations of itching or burning. * The frequency and characterization of adverse events and serious adverse events. * The frequency and characterization of late and/or persistent reactions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
48
Disperse blue 106 in PVP, 0.15 mg/cm2 Disperse blue 106 in PVP, 0.050 mg/cm2 Disperse blue 106 in PVP, 0.017 mg/cm2 PVP Negative Control Bronopol in PVP, 0.75 mg/cm2 Bronopol in PVP, 0.50 mg/cm2 Bronopol in PVP, 0.25 mg/cm2 Bronopol in PVP, 0.125 mg/cm2 Test patches, with allergens, are placed at day one and removed 48 hours later. The duration of the study lasts 21 days. However, the subject is only exposed to the study allergens for 48 hours.
Dermatology Specialists PSC
Louisville, Kentucky, United States
Odense University Hospital
Odense C, Denmark
Diagnostic Performance: Optimal Test Allergen Concentration
Lowest concentration eliciting 1+ or 2+ positive reactions in 70-90% of subjects
Time frame: Visits 3-5: 3-21 days after application
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Percentage (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 3- all subjects
Time frame: Visit 3: 3 days after application
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Percent (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 4- all subjects
Time frame: Visit 4: 7 days after application
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 3- all subjects
Time frame: Visit 3: 3 days after application
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 4- all subjects
Time frame: Visit 4: 7 days after application
Concordance Between Investigational Allergen and Reference Allergen
Concordance between disperse blue or bronopol and the respective reference petrolatum allergen
Time frame: Visit 5: 21 days after patch application
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Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning
Percentage of subjects who exhibited irritation and itching or burning at patch removal (entire panel is evaluated) and late/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 2-21
Adverse Events
The adverse event-reporting period began at application and ended with the Day 21 visit. Adverse events were followed until they resolved. Serious adverse events and those assessed by the investigator as possibly related to the investigational product were to be followed until they resolved or until the investigator assessed them as chronic or stable.
Time frame: Days 0-21