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Evaluation of Gynecological Acceptability of a Health Care Product

Primary Purpose

Atrophic Vaginitis, Vaginal Diseases

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Health care product (intimate gel)
Sponsored by
Herbarium Laboratorio Botanico Ltda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophic Vaginitis

Eligibility Criteria

18 Years - 59 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Health volunteers
  • Non-injured mucosa in the test region;
  • Agreement to comply with safety guidelines to minimize the risk of contamination to COVID-19;
  • Agreement to perform molecular testing to detect COVID-19 to enter the study;
  • 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 59 years old (25 participants from 18 to 39 years old, 25 participants from 40 to premenopause and 25 participants in climacteria);
  • Female participants;
  • Vaginal dryness (slight minimum) - according to questions from the gynecologist.

Exclusion Criteria:

  • Participants who belong to the risk group for COVID-19, that is, aged over 60 years, with diabetes, with chronic cardiovascular, renal and respiratory problems, immunosuppressed or other conditions that the physician deems to belong to the risk group;
  • Participants who have COVID-19, or who have symptoms indicative of the disease in the last 14 days, such as temperature above 36.8°C, fever, cough, shortness of breath, loss of smell, loss of taste and fatigue;
  • 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.

Sites / Locations

  • Allergisa Pesquisa Dermato-Cosmética Ltda

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

female subjects, 18-59 y, healthy

Arm Description

74 female subjects, 18 to 59 years of age, healthy with complaints of vaginal dryness that will receive the heath care product (intimate gel) for home use, under real conditions of use, for 28 ± 2 days.

Outcomes

Primary Outcome Measures

Perceived Hydration
Evaluate the perceived hydration through a subjective questionnaire
Hydration (device)
Evaluate the hydration, through a hydration measurements by chronometry.

Secondary Outcome Measures

Natural defenses preservation (pH)
pH measurements
Natural defenses preservation (microbiota)
bacterioscopic collection

Full Information

First Posted
January 27, 2020
Last Updated
July 30, 2021
Sponsor
Herbarium Laboratorio Botanico Ltda
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1. Study Identification

Unique Protocol Identification Number
NCT04247022
Brief Title
Evaluation of Gynecological Acceptability of a Health Care Product
Official Title
Evaluation of Cutaneous Acceptability and Genital Mucosa Acceptability of a Health Care Product (Intimate Gel), and Interference of Microbiota and pH Around the Vaginal Introit, With Instrumental Evaluation of the Mucosa Hydratation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 9, 2021 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Herbarium Laboratorio Botanico Ltda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The research will be conducted with a product for use in the intimate region in up to 75 research participants who will use the investigational product for 28 ± 2 days. Will be evaluated and followed up throughout the study by a gynecologist to verify the safety and effectiveness of the product and possible adverse events. The study will evaluate the non-interference of a topical use product on the intimate area, helping to preserve the natural defenses. In addition, the epithelial hydration and pH of the intimate area will be evaluated.
Detailed Description
74 female participants, 18 to 59 years of age, healthy with complaints of vaginal dryness. The subjects will be submitted to gynecological evaluation in which pH measurements, hydration measurements and bacterioscopic collection will be performed. Then they will be guided to answer the questionnaires of Perceived Efficacy and Quality of Sexual Life. Next, participants will receive the product for home use, under real conditions of use, for 28 ± 2 days. After 28 ± 2 days of use, subjects will return to the institute, and undergo further evaluations with the gynecologist. New pH measurements, hydration measurements (chronometry), bacterioscopic collection will be performed and the participants will answer the Perceived Efficacy and Quality of Sexual Life questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Vaginitis, Vaginal Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Clinical trial, single-arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
female subjects, 18-59 y, healthy
Arm Type
Experimental
Arm Description
74 female subjects, 18 to 59 years of age, healthy with complaints of vaginal dryness that will receive the heath care product (intimate gel) for home use, under real conditions of use, for 28 ± 2 days.
Intervention Type
Other
Intervention Name(s)
Health care product (intimate gel)
Intervention Description
heath care product (intimate gel) for home use, under real conditions of use, for 28 ± 2 days
Primary Outcome Measure Information:
Title
Perceived Hydration
Description
Evaluate the perceived hydration through a subjective questionnaire
Time Frame
28 ± 2 days
Title
Hydration (device)
Description
Evaluate the hydration, through a hydration measurements by chronometry.
Time Frame
28 ± 2 days
Secondary Outcome Measure Information:
Title
Natural defenses preservation (pH)
Description
pH measurements
Time Frame
28 ± 2 days
Title
Natural defenses preservation (microbiota)
Description
bacterioscopic collection
Time Frame
28 ± 2 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Health volunteers Non-injured mucosa in the test region; Agreement to comply with safety guidelines to minimize the risk of contamination to COVID-19; Agreement to perform molecular testing to detect COVID-19 to enter the study; 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 59 years old (25 participants from 18 to 39 years old, 25 participants from 40 to premenopause and 25 participants in climacteria); Female participants; Vaginal dryness (slight minimum) - according to questions from the gynecologist. Exclusion Criteria: Participants who belong to the risk group for COVID-19, that is, aged over 60 years, with diabetes, with chronic cardiovascular, renal and respiratory problems, immunosuppressed or other conditions that the physician deems to belong to the risk group; Participants who have COVID-19, or who have symptoms indicative of the disease in the last 14 days, such as temperature above 36.8°C, fever, cough, shortness of breath, loss of smell, loss of taste and fatigue; 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.
Facility Information:
Facility Name
Allergisa Pesquisa Dermato-Cosmética Ltda
City
Campinas
State/Province
SP
ZIP/Postal Code
13084-791
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Gynecological Acceptability of a Health Care Product

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