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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000168-18 | EudraCT Number | ||
| WIRB Pr. No.: 20080089 | Other Identifier | Western Institutional Review Board |
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We propose an open, prospective, multi-center Phase III study to evaluate the diagnostic performance and safety of seven new T.R.U.E. Test allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol.Allergen performance and safety will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to at least one of the seven allergens.
Primary endpoint:
The performance (efficacy) of each allergen will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to at least one of the seven allergens. Performance will be based on:
Secondary endpoint:
To evaluate the safety of seven T.R.U.E. Test Panels 3.2 allergens (Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse blue 106 and Bronopol) in adult subjects with suspected contact dermatitis ("consecutives"), and/or in adult subjects with a clinical history of contact dermatitis and a current or previous positive patch test to one (or more) of these 7 allergens ("sensitives"). Evaluations will be based on:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensitives | Experimental | Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria. |
|
| Consecutives | Experimental | Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens | Biological | Polyvinylpyrrolidone (PVP; excipient 1) Hydrocortisone-17-butyrate, 0.020 mg/cm2 in PVP Hydroxypropylcellulose (HPC; excipient 2) MDBGN, 0.0055 mg/cm2 in PVP Bacitracin, 0.60 mg/cm2 in HPC Gold sodium thiosulfate, 0.075 mg/cm2 in HPC Parthenolide, 0.0030 mg/cm2 in PVP Disperse Blue 106, 0.050 mg/cm2 in PVP Bronopol, 0.25 mg/cm2 in PVP Test patches, with allergens, are placed at day one and removed 48 hours later. The duration of the study lasts 21 days. However, the subject is only exposed to the study allergens for 48 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Performance: Concordance Between Investigational Allergen and Reference Allergen at Day 21 | Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen gold sodium thiosulfate and the reference allergen | Visit 5: 21 days after patch application |
| Diagnostic Performance: Concordance | Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen hydrocortisone-17-butyrate and the reference allergen | Visit 5: 21 days after patch application |
| Diagnostic Performance: Concordance | Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen methyldibromo-glutaronitrile and the reference allergen. | Visit 5: 21 days after patch application |
| Diagnostic Performance: Concordance | Concordance: Percentage of subjects who responded positively to TRUE Test allergen bacitracin and the reference allergen. | Visit 5: 21 days after patch application |
| Diagnostic Performance: Concordance | Concordance: Percentage of subjects who responded positively to TRUE Test allergen parthenolide and the reference allergen. | Visit 5: 21 days after patch application |
| Diagnostic Performance: Concordance | Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen disperse blue and the reference allergen. | Visit 5: 21 days after patch application |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Evaluations: All T.R.U.E. Test Allergens | Safety Evaluations: Number of participants who experienced Tape Irritation, Itching or Burning and measure of how well patches adhered to the skin. | Day 2: 48 hours after application |
| Late Reactions: All T.R.U.E. Test Allergens |
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Inclusion Criteria:
Consecutive subjects must report symptoms and/or history consistent with allergic contact dermatitis to at least one of the allergens tested in the study (i.e., subjects are visiting the clinic/physician to diagnose, treat or resolve this condition).
Sensitive subjects must have a positive patch test to one of the following allergens within the past 10 years.
All subjects must be adults over 18 years of age, and otherwise in good health.
Premenopausal female subjects with childbearing potential must consent to a urine pregnancy test; urine test results must be negative for study inclusion.
Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evy Paulsen, M.D., Ph.D | Odense University Hospital | Principal Investigator |
| Joseph Fowler, MD | Dermatology Specialists PSC | Principal Investigator |
| Luz Fonacier, MD | Winthrop University | Principal Investigator |
| Donald V Belsito, MD | American Dermatology Associates | Principal Investigator |
| Jerri Hoskyn, MD | Rivery City Dermatology | Principal Investigator |
| Sandy Skotnicki-Grant, MD | Bay Dermatology Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| River City Dermatology | Little Rock | Arkansas | 72205 | United States | ||
| American Dermatology Associates |
There were no significant events or approaches for the overall study following enrollment but prior to group assignment.
3 June 2008 through 17 August 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Sensitives | Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria. |
| FG001 | Consecutives | Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sensitives | Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria. |
| BG001 | Consecutives |
| 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 | Diagnostic Performance: Concordance Between Investigational Allergen and Reference Allergen at Day 21 | Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen gold sodium thiosulfate and the reference allergen | Subjects with past positive patch test results to gold sodium thiosulfate | Posted | Number | 95% Confidence Interval | percentage of concordant responses | Visit 5: 21 days after patch application |
|
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Day 1 through Day 21
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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 | Sensitives | Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruise on mid sternum from motor vehicle accident | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kim Sullivan | Allerderm | 602-225-0595 |
| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| Diagnostic Performance: Concordance |
Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen bronopol and the reference allergen. |
| Visit 5: 21 days after patch application |
| Diagnostic Performance: Sensitivity and Specificity: Gold Sodium Thiosulfate | Percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen | Visit 5: 21 days after patch application |
| Diagnostic Performance: Sensitivity and Specificity: Hydrocortisone-17-butyrate | The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen | Visit 5: 21 days after patch application |
| Diagnostic Performance: Sensitivity and Specificity: Methyldibromo-glutaronitrile | The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen | Visit 5: 21 days after patch application |
| Diagnostic Performance: Sensitivity and Specificity: Bacitracin | The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen | Visit 5: 21 days after patch application |
| Diagnostic Performance: Sensitivity and Specificity: Parthenolide | The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen | Visit 5: 21 days after patch application |
| Diagnostic Performance: Sensitivity and Specificity: Disperse Blue | The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen | Visit 5: 21 days after patch application |
| Diagnostic Performance: Sensitivity and Specificity: Bronopol | The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen | Visit 5: 21 days after patch application |
Number of subjects who exhibited Late Reactions (reactions that occur at 7-10 days after application). |
| 7-10 days after patch application |
| Persistent Reactions: All T.R.U.E. Test Allergens | Number of Subjects who exhibited Persistent Reactions (reactions that initially occur at 2-4 days after application and persist through 7-21 days after application) | initially occur 2-4 days after application and last through 7-21days after patch application |
| Shawnee Mission |
| Kansas |
| 66216 |
| United States |
| Dermatology Specialists PSC | Louisville | Kentucky | 40202-1864 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| Odense University Hospital | Odense C | DK-5000 | Denmark |
Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Primary | Diagnostic Performance: Concordance | Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen hydrocortisone-17-butyrate and the reference allergen | Subjects with past positive patch test results to hydrocortizone-17-butyrate | Posted | Number | 95% Confidence Interval | percentage of concordant responses | Visit 5: 21 days after patch application |
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| Primary | Diagnostic Performance: Concordance | Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen methyldibromo-glutaronitrile and the reference allergen. | Subjects with past positive patch test results to methyldibromo-glutaronitrile | Posted | Number | 95% Confidence Interval | percentage of concordant responses | Visit 5: 21 days after patch application |
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| Primary | Diagnostic Performance: Concordance | Concordance: Percentage of subjects who responded positively to TRUE Test allergen bacitracin and the reference allergen. | Subjects with past positive patch test results to bacitracin | Posted | Number | 95% Confidence Interval | percentage of concordant responses | Visit 5: 21 days after patch application |
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| Primary | Diagnostic Performance: Concordance | Concordance: Percentage of subjects who responded positively to TRUE Test allergen parthenolide and the reference allergen. | Subjects with past positive patch test results to parthenolide | Posted | Number | 95% Confidence Interval | percentage of concordant responses | Visit 5: 21 days after patch application |
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| Primary | Diagnostic Performance: Concordance | Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen disperse blue and the reference allergen. | Subjects with past positive patch test results to disperse blue | Posted | Number | 95% Confidence Interval | percentage of concordant responses | Visit 5: 21 days after patch application |
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| Primary | Diagnostic Performance: Concordance | Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen bronopol and the reference allergen. | Subjects with past positive test results to bronopol | Posted | Number | 95% Confidence Interval | percentage of concordant responses | Visit 5: 21 days after patch application |
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| Primary | Diagnostic Performance: Sensitivity and Specificity: Gold Sodium Thiosulfate | Percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen | Posted | Number | 95% Confidence Interval | percentage of agreement | Visit 5: 21 days after patch application |
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| Primary | Diagnostic Performance: Sensitivity and Specificity: Hydrocortisone-17-butyrate | The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen | Posted | Number | 95% Confidence Interval | percentage of agreement | Visit 5: 21 days after patch application |
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| Primary | Diagnostic Performance: Sensitivity and Specificity: Methyldibromo-glutaronitrile | The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen | Posted | Number | 95% Confidence Interval | percentage of agreement | Visit 5: 21 days after patch application |
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| Primary | Diagnostic Performance: Sensitivity and Specificity: Bacitracin | The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen | Posted | Number | 95% Confidence Interval | percentage of agreement | Visit 5: 21 days after patch application |
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| Primary | Diagnostic Performance: Sensitivity and Specificity: Parthenolide | The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen | Posted | Number | 95% Confidence Interval | percentage of agreement | Visit 5: 21 days after patch application |
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| Primary | Diagnostic Performance: Sensitivity and Specificity: Disperse Blue | The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen | Posted | Number | 95% Confidence Interval | percentage of agreement | Visit 5: 21 days after patch application |
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| Primary | Diagnostic Performance: Sensitivity and Specificity: Bronopol | The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen | Posted | Number | 95% Confidence Interval | percentage of agreement | Visit 5: 21 days after patch application |
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| Secondary | Safety Evaluations: All T.R.U.E. Test Allergens | Safety Evaluations: Number of participants who experienced Tape Irritation, Itching or Burning and measure of how well patches adhered to the skin. | NOTE: These secondary measurements apply to the entire subject population and were not separated by 'sensitive' or 'consecutive' subjects. | Posted | Number | participants | Day 2: 48 hours after application |
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| Secondary | Late Reactions: All T.R.U.E. Test Allergens | Number of subjects who exhibited Late Reactions (reactions that occur at 7-10 days after application). | Posted | Number | participants | 7-10 days after patch application |
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| Secondary | Persistent Reactions: All T.R.U.E. Test Allergens | Number of Subjects who exhibited Persistent Reactions (reactions that initially occur at 2-4 days after application and persist through 7-21 days after application) | Posted | Number | participants | initially occur 2-4 days after application and last through 7-21days after patch application |
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| 0 |
| 125 |
| 8 |
| 125 |
| EG001 | Consecutives | Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study. | 0 | 110 | 2 | 110 |
| Upper respiratory congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Common head cold symptoms | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Laparoscopic cholecystectomy | Gastrointestinal disorders | Non-systematic Assessment |
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| Right thumb trauma | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Intense itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Intense itching ++ and +++ reactions | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Flare of pre-existing hand eczema during first 3 days of testing | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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