Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens:Bioequivalence of PVP Formulations

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens: Bioequivalence of Polyvinylpyrrolidone (PVP) Formulations

Conditions
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Dermatitis, Contact

Intervention / Treatment
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* Biological: TRUE Test allergens Fragrance Mix and Thimerosol


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 fragrance mix AND/OR thimerosal. All subjects must be adults (18 years of age or older) and otherwise in good health. Pre-menopausal 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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Accepts Healthy Volunteers

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: T.R.U.E. Test allergens Fragrance Mix and Thimerosol<br>Concordance (agreement) between positive patch reactions to fragrance mix (0.43 mg/cm2) in polyvinylpyrrolidone (PVP) vs fragrance mix (0.43 mg/cm2) in hydroxypropylcellulose (HPC) thimerosol (0.008 mg/cm2) in polyvinylpyrrolidone (PVP) vs thimerosol (0.008 mg/cm2) in hydroxypropylcellulose (HPC) fragrance mix T.R.U.E. Test allergen vs fragrance mix reference allergen (petrolatum) thimerosol T.R.U.E. Test allergen vs thimerosol reference allergen (petrolatum) will be measured | Biological: TRUE Test allergens Fragrance Mix and Thimerosol<br>* 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.<br>* Other names: T.R.U.E. TEST Skin Patch Test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritation, Adhesion, Itching/Burning | Frequency of tape-induced irritation at the test site, incomplete panel adhesion and subject-reported sensations of itching or burning. | 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 | Day 2 (48 hours after application) through Day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Thimerosal, Fragrance Mix, PVP formulation, Contact dermatitis