Evaluation of Gynecological Acceptability of 3 Health Care Products

NCT ID: NCT04327947

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-06
• Study Completion Date: 2020-02-21

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.

Conditions

Atrophic Vaginitis; Vaginal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

women, 18-39 y

Health volunteers, 18-39 y, with vaginal dryness

Group Type: EXPERIMENTAL

Hyaluronic acid - Research product 1

Intervention Type: OTHER

Health care product (intimate gel)

Hyaluronic acid - Research product 2

Intervention Type: OTHER

Health care product (intimate gel)

Hyaluronic acid - Comparator product

Intervention Type: OTHER

Health care product (intimate gel)

premenopause women

Health volunteers, 40 years to premenopause, with vaginal dryness

Group Type: EXPERIMENTAL

Hyaluronic acid - Research product 1

Intervention Type: OTHER

Health care product (intimate gel)

Hyaluronic acid - Research product 2

Intervention Type: OTHER

Health care product (intimate gel)

Hyaluronic acid - Comparator product

Intervention Type: OTHER

Health care product (intimate gel)

climacteric women

Health volunteers, climacteric, with vaginal dryness

Group Type: ACTIVE_COMPARATOR

Hyaluronic acid - Research product 1

Intervention Type: OTHER

Health care product (intimate gel)

Hyaluronic acid - Research product 2

Intervention Type: OTHER

Health care product (intimate gel)

Hyaluronic acid - Comparator product

Intervention Type: OTHER

Health care product (intimate gel)

Interventions

Hyaluronic acid - Research product 1

Health care product (intimate gel)

Intervention Type: OTHER

Hyaluronic acid - Research product 2

Health care product (intimate gel)

Intervention Type: OTHER

Hyaluronic acid - Comparator product

Health care product (intimate gel)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Herbarium Laboratorio Botanico Ltda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Allergisa Pesquisa Dermato-Cosmética Ltda

Campinas, , Brazil

Countries

Brazil

Other Identifiers

All-S-EP-076888

Identifier Type: -

Identifier Source: org_study_id