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| ID | Type | Description | Link |
|---|---|---|---|
| 20071738 | Other Identifier | Western Institutional Review Board |
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Open, prospective, multi-center study to evaluate the bioequivalence of povidone (PVP) formulations of 2 T.R.U.E. TEST allergens: fragrance mix and thimerosal.
Bioequivalence will be determined in 40 adult subjects (20 per allergen), who have a clinical history of contact dermatitis and have tested positive to fragrance mix or thimerosal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T.R.U.E. Test allergens Fragrance Mix and Thimerosol | Experimental | Concordance (agreement) between positive patch reactions to
will be measured |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRUE Test allergens Fragrance Mix and Thimerosol | Biological |
Patches are placed at day one and removed 48 hours. The duration of the study lasts 21 days. However, the subject is only exposed the the study allergen for 48 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of Bioequivalence: Concordance | Percent agreement between T.R.U.E. Test allergen in PVP vs HPC is based on a positive test response during at least one post application visit | Up to 21 days |
| Agreement Between TRUE Test Allergen and Reference Allergen | Sensitivity: Agreement between positive results for the test and reference allergen Specificity: Agreement between negative results for the test and reference allergen | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Irritation, Adhesion, Itching/Burning | Frequency of tape-induced irritation at the test site, incomplete panel adhesion and subject-reported sensations of itching or burning. | Visit 2: 48 hours after patch application |
| Frequency of Late and Persistent Reactions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Fowler, MD | Dermatology Specialists PSC | Principal Investigator |
| Luz Fonacier, MD | Winthrop University Hospital | Principal Investigator |
| Donald V. Belsito, MD | American Dermatology Associates | Principal Investigator |
| Jerri Hoskyn, MD | River City Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| River City Dermatology | Little Rock | Arkansas | 72205 | United States | ||
| American Dermatology Associates |
No subject was excluded from the trial following enrollment but before assignment to a group.
The study was conducted at 4 centers in the United States. The first subject was enrolled on Jan 2 2008 and the study completed on Dec 12 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sensitive Subjects | All subjects recruited to this study were to have had previous positive patch test results to one of the allergens tested on the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sensitive Subjects | Subjects with a clinical history and positive patch test (current or previous) to either fragrance mix or thimerosal. Study subjects must be otherwise 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 | Analysis of Bioequivalence: Concordance | Percent agreement between T.R.U.E. Test allergen in PVP vs HPC is based on a positive test response during at least one post application visit | The data from 50 subjects enrolled in the study was analyzed | Posted | Number | 95% Confidence Interval | percentage of agreement | Up to 21 days |
|
Day 0-21
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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 per allergen with a clinical history and positive patch test (current or previous) to either fragrance mix or thimerosal. Study subjects must be otherwise healthy and fulfill entry criteria. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right femoral sheath placed secondary to tronsientischemic attack/carotid stenosis | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bladder Infection | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathy Shannon | SmartPractice | 602-225-0595 | 7208 | kshannon@smarthealth.com |
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| 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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| ID | Term |
|---|---|
| D013849 | Thimerosal |
| ID | Term |
|---|---|
| D005035 | Ethylmercury Compounds |
| D000479 | Alkylmercury Compounds |
| D009941 | Organomercury Compounds |
| D009942 | Organometallic Compounds |
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|
|
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 |
| Day 2 (48 hours after application) through Day 21 |
| Shawnee Mission |
| Kansas |
| 66216 |
| United States |
| Dermatology Specialists PSC | Louisville | Kentucky | 40202-1864 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Agreement Between TRUE Test Allergen and Reference Allergen | Sensitivity: Agreement between positive results for the test and reference allergen Specificity: Agreement between negative results for the test and reference allergen | The data from all enrolled subjects was analyzed. | Posted | Number | 95% Confidence Interval | percentage of agreement | Up to 21 days |
|
|
|
| Secondary | Irritation, Adhesion, Itching/Burning | Frequency of tape-induced irritation at the test site, incomplete panel adhesion and subject-reported sensations of itching or burning. | Posted | Number | percentage of participants | Visit 2: 48 hours after patch application |
|
|
|
| Secondary | Frequency of Late and 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 | Posted | Number | percentage of subjects with reactions | Day 2 (48 hours after application) through Day 21 |
|
|
|
| 1 |
| 50 |
| 5 |
| 50 |
| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Itching and burning | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Itching on/around site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Reports burning sensation, she thinks it might be due to the tape | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Itching at positive patch sites | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D009930 | Organic Chemicals |