Evaluation of Gynecological Acceptability of 3 Health Care Products

Herbarium

Status: Completed

Conditions: Atrophic Vaginitis; Vaginal Disease

Treatments: Other: Hyaluronic acid - Comparator product; Other: Hyaluronic acid - Research product 1; Other: Hyaluronic acid - Research product 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT04327947

All-S-EP-076888

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 3 patient groups

women, 18-39 y

Experimental group

Description:

Health volunteers, 18-39 y, with vaginal dryness

Treatment:

Other: Hyaluronic acid - Comparator product

Other: Hyaluronic acid - Research product 1

Other: Hyaluronic acid - Research product 2

premenopause women

Experimental group

Description:

Health volunteers, 40 years to premenopause, with vaginal dryness

Treatment:

Other: Hyaluronic acid - Comparator product

Other: Hyaluronic acid - Research product 1

Other: Hyaluronic acid - Research product 2

climacteric women

Active Comparator group

Description:

Health volunteers, climacteric, with vaginal dryness

Treatment:

Other: Hyaluronic acid - Comparator product

Other: Hyaluronic acid - Research product 1

Other: Hyaluronic acid - Research product 2