Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents

Study Overview
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Brief Summary
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The objective of the study was to evaluate the diagnostic performance and safety of T.R.U.E. Test allergens in pediatric subjects aged 6-17 years old. In total, 11 allergens were evaluated; 7 new allergens on panels 2.2 and 3.2 and 4 previously approved allergens for which changes were made to dose and excipient.

Detailed Description
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The evaluation of 7 new allergens on panels 2.2 and 3.2, Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol was the original objective of the study. The protocol was amended to include evaluation of 4 reformulated allergens; neomycin sulfate, potassium dichromate, ethylenediamne dihydrochloride and fragrance mix.

Official Title
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Clinical Evaluation of T.R.U.E. Test Panel 3.2 in Children and Adolescents (PREA II)

Conditions
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Allergic Contact Dermatitis

Intervention / Treatment
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* Diagnostic Test: Panels 1.3, 2.2 and 3.2 experimental allergens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptoms and history potentially consistent with allergic contact dermatitis Children and adolescents 6-17 years of age, in general good health Adolescent females 15 years of age or older (or with menarche) must consent to a urine pregnancy test; urine test results must be negative for study inclusion Informed consent must be signed and understood by subject. If underage, informed consent must be signed and understood by parent or legal guardian, consistent with all institutional, local and national regulations Exclusion Criteria: Topical corticosteroid treatment during the last 7 days on or near the test area. Systemic treatment with corticosteroids or other immunosuppressives during the last 7 days. Subjects currently receiving (or received during the previous 3 weeks) other investigational drugs, treatments or devices, or participating in another clinical study 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 activity restrictions (e.g. protecting test panels from excess moisture due to showering or vigorous activity) Subjects unable or unwilling to comply with multiple return visits Female subjects 15 years of age (or with onset of menarche) and older unable to consent to a urine pregnancy test, or those with a positive pregnancy test

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 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
Interventional Model Description: 3 T.R.U.E. Test panels were applied to the paraspinal regional of the back and were to be worn for approximately 48 hours. Post application evaluations were performed at days 3, 4, 7(+1) and 21(+2).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive Response Rates: 7 new and 4 reformulated allergens<br>Subjects will be patched with TRUE Test Panels 1.3, 2,2 and 3.2. Panel 1 allergens nickel sulfate (0.60 mg/cm2), potassium dichromate (0.054 mg/cm2), fragrance mix (0.050 mg/cm2) and ethylenediamine dihydrochloride (0.050 mg/cm2), Panel 2 allergen Methyldibromoglutaronitrile (0.0053 mg/cm2) and Panel 3 allergens Gold sodium thiosulfate (0.075 mg/cm2), Hydrocortisone-17-butyrate (0.020 mg/cm2), Bacitracin (0.60 mg/cm2), Parthenolide (0.0030 mg/cm2), Disperse blue 106 (0.050 mg/cm2 in PVP), 2-Bromo-2-nitropropane-1,3-diol (Bronopol) (0.25 mg/cm2) will be evaluated | Diagnostic Test: Panels 1.3, 2.2 and 3.2 experimental allergens<br>* Three allergen panels will be applied to the upper backs of study subjects and will be worn for 48 hours. Allergen test sites will be evaluated at 3, 4, 7(±1) and 21(±2) days post application.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Reactions at patch test sites were evaluated:Negative: No reaction, Irritant: Discrete, patchy, follicular, or homogenous erythema with no infiltration, Doubtful: Faint macular or homogenous erythema with no infiltration, 1+: Faint macular or homogenous erythema with no infiltration, 2+: Erythema, papules, infiltration, discrete vesicles 3+: Coalescing vesicles, bullous reaction | Investigator Determination of Positive Reaction: 21 days post application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Late or Persistent Positive Patch Test Reactions | Late reactions are positive reactions that initially occur at 7-21 days after application of the panels. Persistent reactions are positive reactions that persist from one visit to the next. Numbers reported only include late or persistent positive patch test reactions. Not all positive reactions are late or persistent. | Day 7-21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eczema, Contact dermatitis