Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Bronopol and Disperse Blue 106 Dose Response Study

Conditions
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Contact Dermatitis

Intervention / Treatment
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* Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 5 years) to Bronopol OR Current or previous symptoms and/or history consistent with allergic contact dermatitis, and a positive patch test (within the past 5 years) to Disperse blue 106 or Disperse blue 106/124 allergen mix. All subjects must be adults (18 years of age or older) and otherwise in good health. Premenopausal female subjects must consent to a urine pregnancy test; results must be negative for study inclusion. Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations. Exclusion Criteria: Subjects unable to meet inclusion requirements. Women who are breastfeeding or pregnant. Topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area. Systemic treatment during the last 7 days with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents. Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks. Acute dermatitis outbreak or dermatitis on or near the test area on the back. Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity). Subject participation in clinical trials of investigational drugs, treatments or devices other than T.R.U.E. Test during this study or 3 weeks prior to inclusion in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sensitives<br>Subjects with a clinical history and positive patch test (current or previous) to either Disperse Blue 106 or Bronopol. Subjects must otherwise be healthy and fulfill entry criteria. | Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens<br>* 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.<br>* Other names: T.R.U.E. TEST® Skin Patch Test: Panel 3.2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Performance: Optimal Test Allergen Concentration | Lowest concentration eliciting 1+ or 2+ positive reactions in 70-90% of subjects | 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 | 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 | 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 | 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 | 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 | Visit 5: 21 days after patch application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Days 0-21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dermatitis, Contact, Bronopol, Disperse Blue 106