Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents

Study Overview
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Brief Summary
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Open, prospective, single-site, non-randomized study of the efficacy and safety of T.R.U.E. TEST allergens in children and adolescents ages 6-18.

Detailed Description
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Three T.R.U.E. TEST panels (1.1, 2.1 and 3.1) containing 28 allergens and a negative control will be applied to the skin on the subject's back and worn for approximately 48 hours. Patch test site skin reactions will be evaluated at days 2, 3 (+1), 7 and 21 following panel application

Official Title
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Clinical Evaluation of T.R.U.E. TEST® Panel 1.1, 2.1 and 3.1: in Children and Adolescents

Conditions
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Dermatitis, Contact

Intervention / Treatment
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* Biological: T.R.U.E. Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptoms and history potentially consistent with allergic contact dermatitis based on symptoms and clinical history (i.e., subjects are visiting the clinic/physician to diagnose, treat or resolve this condition). Children and adolescents 6 to 18 years of age, and 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 immunosuppressive 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: 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: TRUE Test panels 1.1, 2.1, 3.1<br>All subjects were patched with 3 T.R.U.E. Test panels containing 28 allergens and 1 negative control. | Biological: T.R.U.E. Test<br>* 48 hour application of 28 allergens and negative control<br>* Other names: NA no other names;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Reactions: Nickel Sulfate | Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4 | Visit 3: 3-4 after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Neomycin Sulfate | Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Wool Alcohol | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Potassium Dichromate | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Caine Mix | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 72-96 hours after patch application, Visit 4: 1 week after patch application | 
| Positive Reactions: Fragrance Mix | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Colophony | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Paraben Mix | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Negative Control | Number of subjects with positive reactions recorded at visit 3 and/or visit 4. | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Balsam of Peru | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Ethylenediamine Dihydrochloride | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days week after patch application | 
| Positive Reactions: Cobalt Dichloride | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: P-tert Butylphenol Formadehyde Resin | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Epoxy Resin | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Carba Mix | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Black Rubber Mix | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Cl+Me-Isothiazolinone | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Quaternium-15 | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Mercaptobenzothiazole | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: p-Phenylenediamine | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Formaldehyde | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Mercapto Mix | Number of subjects with positive reactions at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Thimerosal | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Thiuram Mix | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Diazolidinyl Urea | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Imidazolidinyl Urea | Number of subjects with positive reactions at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Budesonide | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Tixocortol-21-pivalate | Number of subjects with positive reactions at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 
| Positive Reactions: Quinoline Mix | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Reactions: Nickel Sulfate | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Neomycin Sulfate | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application | 
| Late Reactions: Wool Alcohol | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Potassium Dichromate | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Caine Mix | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Fragrance Mix | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Colophony | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Paraben Mix | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Negative Control | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Balsam of Peru | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Ethylenediamine Dihydrochloride | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days week after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Cobalt Dichloride | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: P-tert Butylphenol Formadehyde Resin | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Epoxy Resin | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Carba Mix | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Black Rubber Mix | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Cl+Me-Isothiazolinone | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Quaternium-15 | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Mercaptobenzothiazole | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: p-Phenylenediamine | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Formaldehyde | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Mercapto Mix | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Thimerosal | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Thiuram Mix | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Diazolidinyl Urea | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Imidazolidinyl Urea | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Budesonide | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Tixocortol-21-pivalate | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Late Reactions: Quinoline Mix | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | 
| Persistent Reactions: Nickel Sulfate | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Neomycin Sulfate | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Wool Alcohol | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Potassium Dichromate | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Caine Mix | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Fragrance Mix | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Colophony | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Paraben Mix | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Negative Control | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Balsam of Peru | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Ethylenediamine Dihydrochloride | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Cobalt Dichloride | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: P-tert Butylphenol Formadehyde Resin | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Epoxy Resin | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Carba Mix | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Black Rubber Mix | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Cl+Me-Isothiazolinone | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Quaternium-15 | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: p-Phenylenediamine | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Formaldehyde | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Mercapto Mix | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Thimerosal | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Thiuram Mix | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Diazolidinyl Urea | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Imidazolidinyl Urea | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Budesonide | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Tixocortol-21-pivalate | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Quinoline Mix | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Persistent Reactions: Mercaptobenzothiazole | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | 
| Panel Adhesion Evaluation | Panel Adhesion was evaluated according to the following score scale: Off: Test panel fell off, Poor: little to no skin to panel contact, Fair: skin to panel contact variable, tape edges lifting, Good: skin contact acceptable, some tape edges loose; Excellent, skin contact good, tape edges adherent. | Visit 2 (day 1) prior to panel removal. | 
| Panel Irritation | Panel Irritation was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol) | Visit 2 (day 1) following to panel removal. | 
| Subject Reported Itching and Burning | Subject reported itching/burning was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol) | Visit 2 (day 1) following to panel removal. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allergic, contact dermatitis, contact allergy, Type IV, Children, TRUE TEST