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| Name | Class |
|---|---|
| Medcin Instituto da Pele | UNKNOWN |
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This is a single-centre, single-blind, non-comparative clinical trial to assess the safety of the investigational product through clinical probability assessment.
Thirty-three female participants, aged between 18-45, will be required. Assessment of dermal (dermatological) and gynecological acceptance, in addition to pH measurements and vaginal force collection for microbiological analysis at the beginning and end of the study.
This is a single-centre, single-blind, non-comparative clinical trial to assess the safety of the investigational product through clinical probability assessment.
Thirty-three female participants, aged between 18-45, will be required. Assessment of dermal (dermatological) and gynecological acceptance, in addition to pH measurements and vaginal force collection for microbiological analysis at the beginning and end of the study.
Participants will remain in the study for a minimum period of 30 days, using the product for the same period according to the flow below:
Flow of Visits:
Visit 01 (D0)
Visit 02 (D30 ±2 days)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stryphnodendron Adstringens (Barbatimão) | Experimental | Intimate Soap |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stryphnodendron Adstringens 3% - once daily post bath | Drug | Intimate Soap |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dermatological and gynecological evaluation criteria | Assess the presence of any clinical signs/symptoms in the vulva, anal and vaginal region by visually observing the mons pubis, labia majora, labia minora, clitoris, vaginal vestibule, urethral orifice, perineum and anal region, with application of a 2-point categorical scale (0=no, 1=yes) | Immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment | Clinical signs and/or symptoms of adverse events | Assessment of the occurrence and intensity of erythema, edema, scaling and vesiculation, using a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sérgio Schalka, MD | Contact | (55) (11) 3683-5366 | contato@medcinpesquisa.com.br | |
| Inês P Soares, MD | Contact | (55) (11) 3683-5366 | contato@medcinpesquisa.com.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medcin Instituto da Pele | Osasco | São Paulo | 06023-070 | Brazil |
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