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Assessment of the female intimate area before and after the use of treated and untreated menstrual pads

Crossover clinical study to evaluate the potential of a pH-buffered, prebiotic treated menstrual pad to provide benefits to the skin and intimate microbiome (E008750A)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8dcymd4
Enrollment
Unknown
Registered
2025-08-29
Start date
2025-07-22
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbiota

Interventions

This is a cross-over, randomized, two-arm, single-blind clinical study. A total of 77 healthy adult women, with regular menstrual cycles, and who meet the eligibility criteria will be enrolled. Partic
E07.357.500

Sponsors

Kimberly-Clark Brasil Industria e Comercio De Produtos De Higiene Ltda
Lead Sponsor
Kimberly-Clark Brasil Industria e Comercio De Produtos De Higiene Ltda
Collaborator

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; who menstruates up to 5 to 6 days. Participants must have healthy and intact skin in the test areas and be willing to comply with study requirements

Exclusion criteria

Exclusion criteria: Participants who are pregnant or intending to become pregnant during the study; 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; any other medical condition or history that may compromise the study results or the subject’s safety

Design outcomes

Primary

MeasureTime frame
It is expected to evaluate whether the treated menstrual pad may increase Lactobacillus crispatus abundance compared to the control pad based on genetic sequencing (16S rDNA)—

Secondary

MeasureTime frame
It is expected to evaluate diversity and composition of the microbiome of the intimate area after using each menstrual pad based on genetic sequencing (16S rDNA);It is expected to evaluate whether there is difference on the pH of the intimate area after using each menstrual pad based on measurements of skin pH ;It is expected to evaluate the self-perception of the subjects about the menstrual pads after use of each menstrual pad based on questionnaires—

Countries

Brazil

Contacts

Public ContactJéssica Pereira

Kimberly-Clark Brasil Industria e Comercio De Produtos De Higiene Ltda

jessica.pereira@kcc.com+55(12)991610904

Outcome results

None listed

Source: REBEC (via WHO ICTRP)