Evaluation of Gynecological Acceptability of 3 Health Care Products

Atrophic Vaginitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04327947
• Other study ID #: All-S-EP-076888
• Status: Completed
• Phase: N/A
• Start date: November 6, 2019
• Est. completion date: February 21, 2020

Study information

• Verified date: April 2020
• Source: Herbarium Laboratorio Botanico Ltda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 21, 2020
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophic Vaginitis
• Vaginal Disease
• Vaginal Diseases
• Vaginitis

Intervention

Other:
• Hyaluronic acid - Research product 1
Health care product (intimate gel)
• Hyaluronic acid - Research product 2
Health care product (intimate gel)
• Hyaluronic acid - Comparator product
Health care product (intimate gel)

Locations

Country	Name	City	State
Brazil	Allergisa Pesquisa Dermato-Cosmética Ltda	Campinas

Sponsors (1)

Lead Sponsor	Collaborator
Herbarium Laboratorio Botanico Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived hydration	Evaluate the perceived hydration, through a subjective questionnaire based on "Standard Guide for Sensory Claim Substantiation"	9 days