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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Response Rates: 7 new and 4 reformulated allergens | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panels 1.3, 2.2 and 3.2 experimental allergens | Diagnostic Test | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cory Dunnick, MD | Anschutz Health and Wellness Center, University of Colorado, Aurora, CO | Principal Investigator |
| Joseph Fowler, MD | Dermatology Specialists, Louisville, KY | Principal Investigator |
| Lawrence Eichenfield, MD | Rady Children's Hospital, San Diego | Principal Investigator |
| Patricia Norris, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rady Children's Hospital | San Diego | California | 92123 | United States | ||
| Anschutz Health and Wellness Center, University of Colorado |
Entry criteria required avoidance of systemic or topical (near the test area) corticosteroid treatment during the 7 days prior to patch application, and any treatment with UV light for 3 weeks prior to patch application.
Subjects will be recruited from patients visiting dermatology, allergy or similar medical practices and clinics, and who are likely to require diagnostic patch testing. Study subjects must be otherwise healthy, and fulfill entry criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Evaluation of T.R.U.E. Test Experimental Allergens | 11 experimental patch test allergens:0.60mg/cm2 neomycin, 0.054 mg/cm2 potassium dichromate, 0.50 mg/cm2 fragrance mix, 0.050 mg/cm2 ethylenediamine, 0.075 mg/cm2 gold,0.020 mg/cm2 hydroxycortisone, 0.60 mg/cm2 bacitracin, 0.0030 mg/cm2 parthenolide,0.050 mg/cm2 disperse blue and 0.25 mg/cm2 bronopol were applied to the skin for 48 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Positive Response Rates: 7 New and 4 Reformulated Allergens | 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 Panels 1.3, 2.2 and 3.2 experimental allergens: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Investigator Determination of Positive Reaction: 21 days post application |
|
Days 2-21
Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Evaluation of T.R.U.E. Test Experimental Allergens | Adverse events were captured for subjects 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA (18.0) | Systematic Assessment | Chest pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Shannon | Allerderm(dba) SmartPractice | 602 225 0595 | kshannon@smarthealth.com |
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| ID | Term |
|---|---|
| D017449 | Dermatitis, Allergic Contact |
| D003877 | Dermatitis, Contact |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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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).
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| Day 7-21 |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Dermatology Specialists | Louisville | Kentucky | 40202 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Per protocol population consisted of all subjects who were applied with all panels, whose panels remained in place for approximately 48 hours and returned for all visits. | Posted | Count of Participants | Participants | Day 7-21 |
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| 1 |
| 116 |
| 47 |
| 116 |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Discomfort | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Food allergy | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Pain | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Pyoderma | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Skin depigmentation | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Skin infection | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Staphylococcal infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| D006968 |
| Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Not Tested with this Allergen |
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| Not Tested with this Allergen |
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| Potassium dichromate |
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| Fragrance mix |
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| Ethylenediamine |
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| MDBGN |
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| Gold |
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| Hydrocortisone |
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| Bacitracin |
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| Parthenolide |
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| Disperse Blue |
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| Bronopol |
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