Evaluation of Gynecological Acceptability of 3 Health Care Products

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

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Disease; Atrophic Vaginitis
• Intervention / Treatment: Other: Hyaluronic acid - Research product 1; Other: Hyaluronic acid - Research product 2; Other: Hyaluronic acid - Comparator product

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Campinas, Brazil
    • Allergisa Pesquisa Dermato-Cosmetica Ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: women, 18-39 y; Health volunteers, 18-39 y, with vaginal dryness	Other: Hyaluronic acid - Research product 1; Health care product (intimate gel); Other: Hyaluronic acid - Research product 2; Health care product (intimate gel); Other: Hyaluronic acid - Comparator product; Health care product (intimate gel)
Experimental: premenopause women; Health volunteers, 40 years to premenopause, with vaginal dryness	Other: Hyaluronic acid - Research product 1; Health care product (intimate gel); Other: Hyaluronic acid - Research product 2; Health care product (intimate gel); Other: Hyaluronic acid - Comparator product; Health care product (intimate gel)
Active Comparator: climacteric women; Health volunteers, climacteric, with vaginal dryness	Other: Hyaluronic acid - Research product 1; Health care product (intimate gel); Other: Hyaluronic acid - Research product 2; Health care product (intimate gel); Other: Hyaluronic acid - Comparator product; Health care product (intimate gel)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived hydration	Evaluate the perceived hydration, through a subjective questionnaire based on "Standard Guide for Sensory Claim Substantiation"	9 days

Collaborators and Investigators

• Sponsor: Herbarium Laboratorio Botanico Ltda

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2019
• Primary Completion (Actual): December 10, 2019
• Study Completion (Actual): February 21, 2020

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 27, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vaginal Diseases; Vaginitis; Atrophic Vaginitis; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: All-S-EP-076888

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No