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The purpose of this test is to evaluate the sensitizing potential of a personal lubricant, as a result of repeated occlusive patch. The intervention will be applied for a total of 9 induction applications, followed by an approximately 2 week rest period, then followed by a 24-72 hour Challenge applications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy subject | Experimental | Healthy subjects exposed to "Chameleon" personal lubricant via occlusive patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Chameleon" Personal Lubricant | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge | 24, 48 and 72 hours after patch application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynne B Harrison, PhD | Harrison Research Laboratories, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harrison Research Laboratories, Inc. | Union | New Jersey | 07083 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Subject | Healthy subjects exposed to Trojan "Chameleon" personal lubricant via occlusive patch Trojan "Chameleon" Personal Lubricant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Subject | Healthy subjects exposed to Trojan "Chameleon" personal lubricant via occlusive patch Trojan "Chameleon" Personal Lubricant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Number of Patients That Showed Sensitization Reaction to the Test Material at Challenge | Posted | Count of Participants | Participants | 24, 48 and 72 hours after patch application |
|
|
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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 | Healthy Subject | Healthy subjects exposed to Trojan "Chameleon" personal lubricant via occlusive patch Trojan "Chameleon" Personal Lubricant |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annahita Ghassemi | Church & Dwight Co., Inc | 6098061200 | annahita.ghassemi@churchdwight.com |
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| ID | Term |
|---|---|
| D004890 | Erythema |
| D004487 | Edema |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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All participants receive the same interventions
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| 0 |
| 222 |
| 0 |
| 222 |
Confidentiality agreement in place with PIs.
| D013568 | Pathological Conditions, Signs and Symptoms |