Atrophic Vaginitis, Vaginal Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERHyaluronic acid - Research product 1
Health care product (intimate gel)
OTHERHyaluronic acid - Research product 2
Health care product (intimate gel)
OTHERHyaluronic acid - Comparator product
Health care product (intimate gel)
Sponsors
Herbarium Laboratorio Botanico Ltda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Clinical trial, triple arm, randomized
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Health volunteers * Non-injured mucosa in the test region; * Agreement to adhere to study procedures and requirements and attend the institute on the day(s) and time(s) determined for the evaluations; * Ability to consent to their participation in the study; * Age from 18 to 70 years old; * Female participants; * Vaginal dryness (slight minimum) - according to questions from the gynecologist.
Exclusion criteria
* Pregnancy or breastfeeding; * Skin pathology in the area of application of the product; * Diabetes Mellitus type 1; insulin-dependent diabetes; presence of complications due to diabetes (retinopathy, nephropathy, neuropathy); presence of diabetes-related dermatoses (plantar ulcer, lipoid necrobiosis, annular granuloma, opportunistic infections); history of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma; * Current use of the following medications for topical or systemic use: corticosteroids, immunosuppressants and antihistamines; * Skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis; * History of reaction to the category of the tested product; * Other diseases or medications that may directly interfere with the study or endanger the health of the research participant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived hydration | 9 days | Evaluate the perceived hydration, through a subjective questionnaire based on Standard Guide for Sensory Claim Substantiation |
Countries
Brazil
Outcome results
None listed