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| Name | Class |
|---|---|
| Allergisa Pesquisa Dermato-Cosmetica LTDA | INDUSTRY |
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Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications.
Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications. This study aim to address the target population, subjects with controlled diabetes, to verify the improvement of texture, elasticity, and general appearance of the skin through the application of the cosmetic product Apotech®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Body moisturizer Apotech® | Experimental | Instructions for use: Massage the product in the body twice a day (morning and evening) with gentle movements until completely absorption. Daily use for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Body moisturizer | Other | Daily body moisturizer application for skin protection and barrier. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin general appearance | Standard guide for sensory claim substantiation - ASTM | 28 days |
| Skin texture | Standard guide for sensory claim substantiation - ASTM | 28 days |
| Skin hydration | Standard guide for sensory claim substantiation - ASTM | 28 days |
| Skin elasticity and visible cracking | Standard guide for sensory claim substantiation - ASTM | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Sensory evaluation of the product | Standard questions | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucas O. Guerra, MSc | Allergisa Pesquisa Dermato-Cosmetica LTDA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergisa Pesquisa Dermato-Cosmetica | Campinas | São Paulo - Brazil | 13087-548 | Brazil |
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| ID | Term |
|---|---|
| D012875 | Skin Diseases, Metabolic |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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This study aim to verify the improvement of texture, elasticity and general appearance of the skin through the application of the cosmetic product Apotech®.
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