Evaluation of Gynecological Acceptability of a Health Care Product

NCT04247022 | Completed

• 1 other identifier: All-SE-ES-074832
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrophic Vaginitis; Vaginal Diseases

Outcome Measures

Primary Outcomes (2)

• Perceived Hydration

  Evaluate the perceived hydration through a subjective questionnaire

  28 ± 2 days

• Hydration (device)

  Evaluate the hydration, through a hydration measurements by chronometry.

  28 ± 2 days

Secondary Outcomes (2)

• Natural defenses preservation (pH)

  28 ± 2 days

• Natural defenses preservation (microbiota)

  28 ± 2 days

Study Arms (1)

female subjects, 18-59 y, healthy

EXPERIMENTAL

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.

Other: Health care product (intimate gel)

Interventions

Health care product (intimate gel) OTHER

heath care product (intimate gel) for home use, under real conditions of use, for 28 ± 2 days

female subjects, 18-59 y, healthy

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Herbarium Laboratorio Botanico Ltda: lead

Study Sites (1)

Allergisa Pesquisa Dermato-Cosmética Ltda

Campinas, São Paulo, 13084-791, Brazil

Location

MeSH Terms

Conditions

Atrophic Vaginitis; Vaginal Diseases

Condition Hierarchy (Ancestors)

Vaginitis; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Clinical trial, single-arm

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: April 9, 2021
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: August 2, 2021

Record last verified: 2021-07

Locations

BR (1)