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Determine the ability of the study material (personal lubricant) to cause sensitization by repeated topical application to the skin of humans under controlled patch test conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human Repeat Insult Patch Test | Experimental | Approximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Novel lubricant Miami Fragrance | Device |
| ||
| Experimental: Novel lubricant Miami no Fragrance |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 24, 48, and 72 hours after patch application |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Human Repeat Insult Patch Test | Experimental: Human Repeat Insult Patch Test Approximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | HRIPT | Novel lubricant Miami w/ fragrance Novel lubricant Miami w/o fragrance 510(k) cleared and currently marketed personal lubricant 510(k) cleared and currently marketed 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 | 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 Participants With Adverse Events as a Measure of Safety and Tolerability | Posted | Number | participants | 24, 48, and 72 hours after patch application |
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|
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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 | HRIPT | Experimental: Novel lubricant Miami w/ frag Experimental: Novel Miami w/o frag KY Liquid lubricant Astroglide Gel 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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| Device |
|
| KY Liquid lubricant | Device |
|
| Astroglide Gel lubricant | Device |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 0 |
| 209 |
| 0 |
| 209 |
Master service agreement and confidentiality agreement in place
| D013568 | Pathological Conditions, Signs and Symptoms |