Vulvovaginitis
Conditions
Interventions
This is a randomized, parallel, four-arm, single-blind clinical study. A total of 108 healthy adult women, with regular menstrual cycles, and who meet the eligibility criteria will be enrolled. Partic
27 participants to group 1 (low treatment add-on pantyliner)
27 participants to group 2 (medium treatment add-on pantyliner), e 27 participants to group 3 (higher treatment add-on pantyliner). All participants will be instructed to use their pantyliner, during
Sponsors
Kimberly-Clark Brasil Industria e Comercio De Produtos De Higiene Ltda
Kimberly-Clark Brasil Industria e Comercio De Produtos De Higiene Ltda
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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;It is expected to evaluate the change from baseline in bacterial species of the urogenital microbiome assessed by Q-PCR after 7 and 14 days using the treated pantyliners compared to untreated control pantyliner and among each treated pantyliner. | — |
Countries
Brazil
Contacts
Public ContactJéssica Pereira
Kimberly-Clark Brasil Industria e Comercio De Produtos De Higiene Ltda
Outcome results
None listed