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The objective of this study is to determine the ability of the study material to cause irritation to the skin of humans under controlled patch test conditions. Substances that come into contact with human skin need to be evaluated for their propensity to irritate and/or sensitize. This testing is a modified primary irritancy patch test that can detect weak irritants that require multiple applications to cause a skin reaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Subject | Experimental | Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel lubricant Miami w/ fragrance | Device | 0.2 ml aliquot on occlusive patch |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects That Showed no Significant Irritation | Score of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5). | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Subject | Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 no Significant Irritation | Score of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5). | Posted | Number | 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 | Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annahita Ghassemi | Church & Dwight Co., Inc. | 6098061200 | annahita.ghassemi@churchdwight.com |
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| Novel lubricant Miami no fragrance |
| Device |
0.2 ml aliquot on occlusive patch |
|
| KY Liquid lubricant | Device | 0.2 ml aliquot on occlusive patch |
|
| Astroglide Gel lubricant | Device | 0.2 ml aliquot on occlusive patch |
|
| Wet Platinum lubricant | Device | 0.2 ml aliquot on occlusive patch |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 0 |
| 41 |
| 0 |
| 41 |
Master service agreement and confidentiality agreement in place