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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1115-3484 | Other Identifier | UTN |
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Primary Objective:
- To prove the efficacy superiority in reducing the genital odor and increase hydration in mucosa genital comparing the use of Dermacyd (different fragrances) and Glycerine Vegetal Soap Granado Traditional
Secondary Objective:
- To evaluate the safety in normal conditions of use, verifying clinical signs and lab exams.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dermacyd (different fragrances) | Experimental | Day 1 until 30: Investigational Product (Dermacyd) Day 31 until 37: wash-out Day 38 until 67: Glycerine Vegetal Soap Granado Traditional |
|
| Glycerine Vegetal Soap Granado Traditional | Active Comparator | Day 1 until 30: Glycerine Vegetal Soap Granado Traditional Day 31 until 37: wash-out Day 38 until 67: Investigational Product (Dermacyd) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LACTIC ACID (Dermacid) | Drug | Route of administration: local |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of genital odor and increase hydration in genital mucosa | Patient's questionnaire will be completed at V1, V2 and V4. Reduction of vaginal odor, increase in the moisture area, and perception about some items like foam, facility of rinsing, final touch of the mucosa, final fragrance, and cleaning sensation will be rated on a 5-point scale. | From the treatment start to the end of the study (day 67) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the integrity of the mucosa | Onset of erythema, edema, scaling, blisters or other clinical sign will be evaluated. | From the treatment start to the end of the study (day 67) |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Investigational Site Number 076-001 | Osasco | 06023-000 | Brazil |
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| ID | Term |
|---|---|
| D019344 | Lactic Acid |
| ID | Term |
|---|---|
| D007773 | Lactates |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Glycerine Vegetal Soap Granado Traditional | Drug | Route of administration: local |
|