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The purpose of this study is to check the safety under normal conditions of use through the emergence of signs of irritability and sensitization of the genital mucosa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KL029 Intimate Lubricant Gel | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Emergence of signs of irritability and sensitization in the genital mucosa through Wilcoxon test | For the safety assessment, the variables will be evaluated for each experimental period using one-tailed Wilcoxon test to investigate the following hypotheses: H0: The median of the results of the variable under study is zero (no irritation) H1: The median of the results of the variable under study is greater than zero (no irritation) The Wilcoxon test is used because it is the ideal to compare variables collected with ordinal scale with a reference value. In this study, the reference value is zero (no irritation). The expectation is the absence of positive safety, ie higher scores than zero. If there are positive evidence of (mild, moderate or severe) for parameters erythema, peeling,blistering and swelling, the results are statistically evaluated. | 40 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 21, 2016 | |
| Reset | Nov 9, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 21, 2016 | Nov 9, 2016 |
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