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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-007130-19 | EudraCT Number | ||
| WIRB Pr. No.: 20072233 | Other Identifier | Western Institutional Review Board |
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We propose a prospective, multi-center, double-blind, randomized study comparing the diagnostic performance (primary) and safety (secondary) of 3 concentrations of Disperse blue 106 and 4 concentrations of Bronopol in 40 adult subjects (20 subjects per allergen) with a clinical history of contact dermatitis and a positive patch test (current or previous) to the corresponding reference petrolatum allergen ("sensitives").
Primary endpoint:
To evaluate the diagnostic performance of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include:
Secondary endpoint:
To evaluate the safety of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensitives | Experimental | Subjects with a clinical history and positive patch test (current or previous) to either Disperse Blue 106 or Bronopol. Subjects must otherwise be healthy and fulfill entry criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens | Biological | Disperse blue 106 in PVP, 0.15 mg/cm2 Disperse blue 106 in PVP, 0.050 mg/cm2 Disperse blue 106 in PVP, 0.017 mg/cm2 PVP Negative Control Bronopol in PVP, 0.75 mg/cm2 Bronopol in PVP, 0.50 mg/cm2 Bronopol in PVP, 0.25 mg/cm2 Bronopol in PVP, 0.125 mg/cm2 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: Optimal Test Allergen Concentration | Lowest concentration eliciting 1+ or 2+ positive reactions in 70-90% of subjects | Visits 3-5: 3-21 days after application |
| Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | Percentage (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 3- all subjects | Visit 3: 3 days after application |
| Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | Percent (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 4- all subjects | Visit 4: 7 days after application |
| Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 3- all subjects | Visit 3: 3 days after application |
| Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 4- all subjects | Visit 4: 7 days after application |
| Concordance Between Investigational Allergen and Reference Allergen | Concordance between disperse blue or bronopol and the respective reference petrolatum allergen |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | Percentage of subjects who exhibited irritation and itching or burning at patch removal (entire panel is evaluated) and late/persistent reactions. Late reactions occur 7-10 days after patch application Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application |
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Inclusion Criteria:
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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Specialists PSC | Louisville | Kentucky | 40202-1864 | United States | ||
| Odense University Hospital |
There were no significant events or approaches which caused enrolled participants to be excluded from the trial before assignment to a group.
Dates of recruitment: 16 June 2008 through 7 April 2009. This study was conducted at two investigational sites located in Denmark (E Paulsen) and the United States (J Fowler).
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| ID | Title | Description |
|---|---|---|
| FG000 | Sensitives | Subjects with a clinical history and positive patch test (current or previous) to either Disperse Blue 106 or Bronopol. Subjects must otherwise be healthy and fulfill entry criteria. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The analysis included all enrolled subjects but it should be noted that subject 5-D220 was not sensitive to either allergen and thus was not included in either population of sensitive subjects; the subject was included in the population of all enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sensitives | Subjects with a clinical history and positive patch test (current or previous) to either Disperse Blue 106 or Bronopol. Subjects must otherwise be healthy and fulfill entry criteria. |
| 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: Optimal Test Allergen Concentration | Lowest concentration eliciting 1+ or 2+ positive reactions in 70-90% of subjects | Percentage is based on subjects sensitive to each allergen. Results from one subject not included due to no past history of positive patch test. | Posted | Number | percentage of participants | Visits 3-5: 3-21 days after application |
|
Day 1 through Day 21
Serious or possibly related events were to be followed until they resolved or assessed as chronic or stable
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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 | All Subjects |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upset stomach | Gastrointestinal disorders | Non-systematic Assessment | Event was not related to the investigational panel. |
There were no limitations or caveats which led to unreadable or uninterpretable data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evy Paulsen, MD | Institute of Clinical Research, Department of Dermoto Venerology and Allergy Center | +45 65 41 27 08 |
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| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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|
|
| Visit 5: 21 days after patch application |
| Day 2-21 |
| Adverse Events | The adverse event-reporting period began at application and ended with the Day 21 visit. Adverse events were followed until they resolved. Serious adverse events and those assessed by the investigator as possibly related to the investigational product were to be followed until they resolved or until the investigator assessed them as chronic or stable. | Days 0-21 |
| Odense C |
| DK-5000 |
| Denmark |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Disperse Blue 0.150 mg/cm2 |
Percentage of positive test responses |
| OG003 | Bronopol 0.125 mg/cm2 | Percentage of positive test responses |
| OG004 | Bronopol 0.250 mg/cm2 | Percentage of positive test responses |
| OG005 | Bronopol 0.500 mg/cm2 | Percentage of positive test responses |
| OG006 | Bronopol 0.750 mg/cm2 | Percentage of positive test responses |
|
|
| Primary | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | Percentage (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 3- all subjects | All subjects | Posted | Number | 95% Confidence Interval | percentage of participants | Visit 3: 3 days after application |
|
|
|
| Primary | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | Percent (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 4- all subjects | Posted | Number | 95% Confidence Interval | percentage of participants | Visit 4: 7 days after application |
|
|
|
| Primary | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 3- all subjects | Data from one subject not included because subject did not have a past positive response to either allergen. | Posted | Number | 95% Confidence Interval | percentage of participants | Visit 3: 3 days after application |
|
|
|
| Primary | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 4- all subjects | Data from one subject not included because subject did not have past positive response to either allergen. | Posted | Number | 95% Confidence Interval | percentage of participants | Visit 4: 7 days after application |
|
|
|
| Primary | Concordance Between Investigational Allergen and Reference Allergen | Concordance between disperse blue or bronopol and the respective reference petrolatum allergen | Data from one subject not included because subject did not have past positive response to either allergen. | Posted | Number | 95% Confidence Interval | percentage of agreement | Visit 5: 21 days after patch application |
|
|
|
| Secondary | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | Percentage of subjects who exhibited irritation and itching or burning at patch removal (entire panel is evaluated) and late/persistent reactions. Late reactions occur 7-10 days after patch application Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application | Data from one subject not included because subject did not have past positive response to either allergen. | Posted | Number | percentage of participants | Day 2-21 |
|
|
|
| Secondary | Adverse Events | The adverse event-reporting period began at application and ended with the Day 21 visit. Adverse events were followed until they resolved. Serious adverse events and those assessed by the investigator as possibly related to the investigational product were to be followed until they resolved or until the investigator assessed them as chronic or stable. | Posted | Number | events | Days 0-21 |
|
|
|
| 0 |
| 48 |
| 2 |
| 48 |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Event could not be attributed to a single allergen or allergen concentration. It was determined to be related to the the entire panel. |
|
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