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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRUE Test panels 1.1, 2.1, 3.1 | Experimental | All subjects were patched with 3 T.R.U.E. Test panels containing 28 allergens and 1 negative control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T.R.U.E. Test | Biological | 48 hour application of 28 allergens and negative control |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Eichenfield, MD | UCSD School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rady Children's Hospital | San Diego | California | 92123 | United States |
No significant events or approaches
Single Site- Rady Children's Hospital Recruiting Period-09 December 2008 (first subject enrolled) 27 October 2009 (last subject exited)
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | T.R.U.E. Test Allergen Panel evaluations |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Study | All subjects were patched with TRUE Test panels 1.1, 2.1 and 3.1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Positive Reactions: Nickel Sulfate | Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 after patch application, Visit 4: 7 days after patch application |
|
|
The Adverse Event-Reporting Period for each study subject began at application of the patch test and ended with the Day 21 visit.
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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 | Safety | Adverse Events |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SE Jacob, MD and L Eichenfield, MD | Rady Children's Hospital, San Diego, CA | 858-576-1700 | 4825 | leichenfield@rchsd.org |
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| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| D017449 | Dermatitis, Allergic Contact |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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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 |
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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Positive Reactions: Neomycin Sulfate | Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Wool Alcohol | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Potassium Dichromate | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Caine Mix | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 72-96 hours after patch application, Visit 4: 1 week after patch application |
|
|
|
| Primary | Positive Reactions: Fragrance Mix | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Colophony | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Paraben Mix | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Negative Control | Number of subjects with positive reactions recorded at visit 3 and/or visit 4. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Balsam of Peru | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Ethylenediamine Dihydrochloride | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days week after patch application |
|
|
|
| Primary | Positive Reactions: Cobalt Dichloride | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
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| Primary | Positive Reactions: P-tert Butylphenol Formadehyde Resin | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Epoxy Resin | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
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|
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| Primary | Positive Reactions: Carba Mix | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
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| Primary | Positive Reactions: Black Rubber Mix | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Cl+Me-Isothiazolinone | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Quaternium-15 | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Mercaptobenzothiazole | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
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|
|
| Primary | Positive Reactions: p-Phenylenediamine | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Formaldehyde | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Mercapto Mix | Number of subjects with positive reactions at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Thimerosal | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Thiuram Mix | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Diazolidinyl Urea | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Imidazolidinyl Urea | Number of subjects with positive reactions at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Budesonide | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Tixocortol-21-pivalate | Number of subjects with positive reactions at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Primary | Positive Reactions: Quinoline Mix | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | Late Reactions: Colophony | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days week after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | Late Reactions: Mercaptobenzothiazole | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | Late Reactions: Formaldehyde | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | Late Reactions: Thimerosal | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | Late Reactions: Budesonide | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | Number of participants analyzed includes all subjects who completed the study. | Posted | Number | participants | 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 |
|
|
|
| Secondary | 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. | All subjects who completed the study are included in the analysis. | Posted | Count of Participants | Participants | Visit 2 (day 1) prior to panel removal. |
|
|
|
| Secondary | Panel Irritation | Panel Irritation was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol) | All subjects who completed the study are included in the analysis. | Posted | Count of Participants | Participants | Visit 2 (day 1) following to panel removal. |
|
|
|
| Secondary | Subject Reported Itching and Burning | Subject reported itching/burning was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol) | All subjects who completed the study are included in the analysis. | Posted | Count of Participants | Participants | Visit 2 (day 1) following to panel removal. |
|
|
|
| 0 |
| 102 |
| 42 |
| 102 |
| Flare-up of rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Boil on forehead | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Headache | Vascular disorders | Non-systematic Assessment |
|
| Fever | Infections and infestations | Non-systematic Assessment |
|
| Reaction around panel 2.1 | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Edema, vesiculation pain on hands | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Worsening of underlying condition | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Slight worsening of spot on leg | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Lesion on right thumb | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Worsening of dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Reaction on place of panel | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D006968 |
| Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Poor |
|
| Fell off |
|
| Panel 2 Adhesion Scores |
|
| Panel 3 Adhesion Scores |
|
|
| Panel 2 Irritation |
|
| Panel 3 Irritation |
|
| Strong |
|
| Panel 2 Itching and Burning |
|
| Panel 3 Itching and Burning |
|