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Evaluation of Gynecological Acceptability of 3 Health Care Products

Primary Purpose

Atrophic Vaginitis, Vaginal Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hyaluronic acid - Research product 1
Hyaluronic acid - Research product 2
Hyaluronic acid - Comparator product
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 - 70 Years (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • Allergisa Pesquisa Dermato-Cosmética Ltda

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

women, 18-39 y

premenopause women

climacteric women

Arm Description

Health volunteers, 18-39 y, with vaginal dryness

Health volunteers, 40 years to premenopause, with vaginal dryness

Health volunteers, climacteric, with vaginal dryness

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 26, 2020
Last Updated
April 1, 2020
Sponsor
Herbarium Laboratorio Botanico Ltda
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1. Study Identification

Unique Protocol Identification Number
NCT04327947
Brief Title
Evaluation of Gynecological Acceptability of 3 Health Care Products
Official Title
Evaluation of Gynecological Acceptability of 3 Health Care Products (Intimate Gel)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 6, 2019 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
February 21, 2020 (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 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Clinical trial, triple arm, randomized
Masking
Participant
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
women, 18-39 y
Arm Type
Experimental
Arm Description
Health volunteers, 18-39 y, with vaginal dryness
Arm Title
premenopause women
Arm Type
Experimental
Arm Description
Health volunteers, 40 years to premenopause, with vaginal dryness
Arm Title
climacteric women
Arm Type
Active Comparator
Arm Description
Health volunteers, climacteric, with vaginal dryness
Intervention Type
Other
Intervention Name(s)
Hyaluronic acid - Research product 1
Intervention Description
Health care product (intimate gel)
Intervention Type
Other
Intervention Name(s)
Hyaluronic acid - Research product 2
Intervention Description
Health care product (intimate gel)
Intervention Type
Other
Intervention Name(s)
Hyaluronic acid - Comparator product
Intervention Description
Health care product (intimate gel)
Primary Outcome Measure Information:
Title
Perceived hydration
Description
Evaluate the perceived hydration, through a subjective questionnaire based on "Standard Guide for Sensory Claim Substantiation"
Time Frame
9 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Allergisa Pesquisa Dermato-Cosmética Ltda
City
Campinas
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Gynecological Acceptability of 3 Health Care Products

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