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The research was conduct with 3 different products for use in the intimate region in up to 70 research participants, that use the investigational product by 35 ± 2 days. The subjects were follow up throughout the study by a gynecologist for verification of safety, effectiveness and possible adverse events.
At this study, 70 female participants, 18 to 70 years, healthy with complaints of vaginal dryness used the 3 investigational product, each one by 9 days. Between the changes of product use, there were 4 days of wash out. At the 9th day, the participants answered assessment questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| women, 18-39 y | Experimental | Health volunteers, 18-39 y, with vaginal dryness |
|
| premenopause women | Experimental | Health volunteers, 40 years to premenopause, with vaginal dryness |
|
| climacteric women | Active Comparator | Health volunteers, climacteric, with vaginal dryness |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid - Research product 1 | Other | Health care product (intimate gel) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perceived hydration | Evaluate the perceived hydration, through a subjective questionnaire based on "Standard Guide for Sensory Claim Substantiation" | 9 days |
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Inclusion Criteria:
Exclusion Criteria:
corticosteroids, immunosuppressants and antihistamines;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergisa Pesquisa Dermato-Cosmética Ltda | Campinas | Brazil |
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| ID | Term |
|---|---|
| D059268 | Atrophic Vaginitis |
| D014623 | Vaginal Diseases |
| ID | Term |
|---|---|
| D014627 | Vaginitis |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Clinical trial, triple arm, randomized
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| Hyaluronic acid - Research product 2 | Other | Health care product (intimate gel) |
|
| Hyaluronic acid - Comparator product | Other | Health care product (intimate gel) |
|
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |