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The purpose of this study is to prove the product tested does not cause photoirritation or photosensitization reactions when exposed to sun light.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | This study is designed as a single group assignment, because the 4 dressings (3 placebos and 1 containing the product) will be applied in all volunteers. This means that the region in which the tested product will be applied will be compared with the other placebo regions in the same volunteer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KL029 Intimate Lubricant Gel | Device | All the volunteers will receive the application of four dressings (3 placebos and 1 containing the tested product). After a certain period of time, photoirritation and photosensitization will be measured through the evaluation of tested region. |
| Measure | Description | Time Frame |
|---|---|---|
| Photoirritation as measured through the use of dressings containing tested product and placebo | The photoirritation will be measured with the use of four dressings that will be applied in the volunteer (3 dresssings containing different placebos and 1 containing the product). After some hours, the region is evaluated and irradiated with UVA. That procedure occurs during the period of five days. | 05 days |
| Photosensitization as measured through the use of dressings containing tested product and placebo | The photosensitization will be measured with the use of four dressings that will be applied in the volunteer (3 dresssings containing different placebos and 1 containing the product). After some hours, the region is evaluated and irradiated with UVA. That procedure occurs during the period of 32 days. | 32 days |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy and lactation
Use of anti-inflammatory and immunosuppressive from 30 days up to three months prior to selection;
Diseases that cause immune suppression;
Use of photosensitizing drugs;
History or photodermatoses activities;
Personal or family history of photoinduced skin cancer;
Presence of precursor lesions of skin cancer, such as melanocytic nevi and actinic keratoses;
Intense sun exposure in the experiment area Use of new drugs and/or cosmetics during the experiment;
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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 |