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to determine the ability of the test article to cause irritation to the skin of humans under controlled patch test conditions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy subject | Experimental | Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trojan "Chameleon" Personal Lubricant | Device | silicone base with sensate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale | 14 days | |
| Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Dosik, MD | TKL Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TKL Research Inc | Fair Lawn | New Jersey | 07410 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Subject | Healthy subjects exposed to Trojan "Chameleon" Personal Lubricant applied by occlusive patch Trojan "Chameleon" Personal Lubricant: silicone base with sensate |
| 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 applied by occlusive patch Trojan "Chameleon" Personal Lubricant: silicone base with sensate |
| 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 Subjects That Showed Erythema Based on 5 Point Scoring Scale | Posted | Count of Participants | Participants | 14 days |
|
|
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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 applied by occlusive patch Trojan "Chameleon" Personal Lubricant: silicone base with sensate |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annahita Ghassemi | Church & Dwight Co., Inc | 6098061200 | annahita.ghassemi@churchdwight.com |
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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 |
|
|
| Primary | Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale | Posted | Count of Participants | Participants | 14 days |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
Confidentiality agreement in place with PI