Evaluation of Gynecological Acceptability of 3 Health Care Products

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Gynecological Acceptability of 3 Health Care Products (Intimate Gel)

Conditions
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Atrophic Vaginitis, Vaginal Disease

Intervention / Treatment
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* Other: Hyaluronic acid - Research product 1
* Other: Hyaluronic acid - Research product 2
* Other: Hyaluronic acid - Comparator product


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Clinical trial, triple arm, randomized
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: women, 18-39 y<br>Health volunteers, 18-39 y, with vaginal dryness | Other: Hyaluronic acid - Research product 1<br>* Health care product (intimate gel)<br>Other: Hyaluronic acid - Research product 2<br>* Health care product (intimate gel)<br>Other: Hyaluronic acid - Comparator product<br>* Health care product (intimate gel)<br>|
| Experimental: premenopause women<br>Health volunteers, 40 years to premenopause, with vaginal dryness | Other: Hyaluronic acid - Research product 1<br>* Health care product (intimate gel)<br>Other: Hyaluronic acid - Research product 2<br>* Health care product (intimate gel)<br>Other: Hyaluronic acid - Comparator product<br>* Health care product (intimate gel)<br>|
| Active Comparator: climacteric women<br>Health volunteers, climacteric, with vaginal dryness | Other: Hyaluronic acid - Research product 1<br>* Health care product (intimate gel)<br>Other: Hyaluronic acid - Research product 2<br>* Health care product (intimate gel)<br>Other: Hyaluronic acid - Comparator product<br>* Health care product (intimate gel)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived hydration | Evaluate the perceived hydration, through a subjective questionnaire based on Standard Guide for Sensory Claim Substantiation | 9 days |