Evaluation of Gynecological Acceptability of 3 Health Care Products

Not Applicable

Completed

• Conditions: Vaginal Disease; Atrophic Vaginitis
• Interventions: Other: Hyaluronic acid - Research product 1; Other: Hyaluronic acid - Research product 2; Other: Hyaluronic acid - Comparator product

• Registration Number: NCT04327947
• Lead Sponsor: Herbarium Laboratorio Botanico Ltda

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.

Study Timeline

• Study Start: 2019-11-06
• Primary Completion: 2019-12-10
• Study Completion: 2020-02-21
• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-27
• Study First Posted: 2020-03-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
premenopause women	Hyaluronic acid - Research product 1	Health volunteers, 40 years to premenopause, with vaginal dryness
premenopause women	Hyaluronic acid - Research product 2	Health volunteers, 40 years to premenopause, with vaginal dryness
premenopause women	Hyaluronic acid - Comparator product	Health volunteers, 40 years to premenopause, with vaginal dryness
climacteric women	Hyaluronic acid - Research product 1	Health volunteers, climacteric, with vaginal dryness
women, 18-39 y	Hyaluronic acid - Research product 1	Health volunteers, 18-39 y, with vaginal dryness
women, 18-39 y	Hyaluronic acid - Research product 2	Health volunteers, 18-39 y, with vaginal dryness
women, 18-39 y	Hyaluronic acid - Comparator product	Health volunteers, 18-39 y, with vaginal dryness
climacteric women	Hyaluronic acid - Research product 2	Health volunteers, climacteric, with vaginal dryness
climacteric women	Hyaluronic acid - Comparator product	Health volunteers, climacteric, with vaginal dryness

Primary Outcome Measures

Name	Time	Method
Perceived hydration	9 days	Evaluate the perceived hydration, through a subjective questionnaire based on "Standard Guide for Sensory Claim Substantiation"

Trial Locations

Locations (1)

Allergisa Pesquisa Dermato-Cosmética Ltda; 🇧🇷 Campinas, Brazil