Assessment of the female intimate area before and after the use of treated and untreated pantyliners
- Conditions
- VulvovaginitisC12.050.351.500.894.906.800
- Registration Number
- RBR-77qc49q
- Lead Sponsor
- Kimberly-Clark Brasil Industria e Comercio De Produtos De Higiene Ltda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Female
- Target Recruitment
- Not specified
Females; 18 to 45 years old; in good general health; with regular monthly menstrual cycles that are not expected to menstruate during the study; participants must have healthy and intact skin in the test areas, and be willing to comply with study requirements
Participants that are pregnant or intending to become pregnant during the study, or breast-feeding; participants that have a history of skin conditions or the presence of visible skin conditions on any skin testing sites; history of chronic or currently active gynecological pathologies or urogenital infections in the last 3 months; used systemic and/or topical antibiotics, antifungals, and/or corticosteroids within 4 weeks prior to visit 1 and throughout the study; any other medical condition or history that may compromise the study results or the subject’s safety
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method It is expected to evaluate the change on Lactobacillus species abundance from baseline based genetic sequencing (16S rDNA) after 7 and 14 days wearing treated pantyliners compared to the control pantyliner
- Secondary Outcome Measures
Name Time Method It is expected to evaluate the change from baseline on Lactobacillus species abundance based on genetic sequencing (16S rDNA) after 7 and 14 days wearing the treated pantyliners among each other;It is expected to evaluate the change from baseline on diversity and composition of others urogenital microbial communities assessed by alpha and beta diversity based on genetic sequencing (16S rDNA) after 7 and 14 days wearing the treated pantyliners compared among each other and compared to the control pantyliner;It is expected to evaluate various biophysical measurements in the intimate area compared between (and among) the treated groups and the control group at 7 and 14 days;It is expected to evaluate the self-perception of the subjects about the treated pantyliners and the control pantyliner during the study, after 7 and 14 days of product use, based on questionnaires