Status:
COMPLETED
Evaluation of Gynecological Acceptability of 3 Health Care Products
Lead Sponsor:
Herbarium Laboratorio Botanico Ltda
Conditions:
Atrophic Vaginitis
Vaginal Disease
Eligibility:
FEMALE
18-70 years
Phase:
NA
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 th...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2020
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04327947
Start Date
November 6 2019
End Date
February 21 2020
Last Update
April 3 2020
Active Locations (1)
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1
Allergisa Pesquisa Dermato-Cosmética Ltda
Campinas, Brazil