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Completed

NCT Number: NCT04327947

Evaluation of Gynecological Acceptability of 3 Health Care Products

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.

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Key information

Conditions

Atrophic Vaginitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vaginal Disease Vaginal Diseases Vaginitis

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Allergisa Pesquisa Dermato-Cosmética Ltda

Campinas, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyaluronic acid - Research product 1

Other

Health care product (intimate gel)

Hyaluronic acid - Research product 2

Other

Health care product (intimate gel)

Hyaluronic acid - Comparator product

Other

Health care product (intimate gel)

Primary outcomes

  1. Perceived hydration

    Time frame: 9 days

    Evaluate the perceived hydration, through a subjective questionnaire based on "Standard Guide for Sensory Claim Substantiation"

Sponsors and collaborators

Lead sponsor

Herbarium Laboratorio Botanico Ltda

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 31, 2020
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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