Abstract
While intimate feminine hygiene products are widely used as part of daily cleansing routines, little is known about how these products impact the vulvovaginal area and its microbiome stability. This 4 week clinical study assessed tolerance of a novel gel wash containing lactic acid (pH 4.2) for external daily use when used on the external genital area and its effects on skin moisturization, vulvar skin pH, and the vulvar microbiome. After a 7 day pre-study conditioning period, 36 healthy females in three balanced age groups (18–29, 30–44, and 45–55 years) used the gel wash to cleanse their external genital area (mons pubis and vulva) and entire body at least once per day for 28 days. Skin tolerance of the gel wash was assessed by the gynecologist. Effects of the gel wash on vulvar skin microbiota were studied by performing bacterial 16S rRNA and fungal internal transcribed spacer (ITS) microbial richness and diversity analysis. Based on gynecologic assessment after 28 days of use, the gel wash showed acceptable tolerance, with no signs of increased dryness, redness, edema, itching, stinging, or burning. Use of the gel wash was associated with a significant increase in both short-term (single application) and longer-term (daily use for 28 days) skin moisturization. There was no significant change in vulvar skin pH over time with daily product use, and the gel wash did not significantly affect the natural vulvar microbiome species richness or diversity for bacteria or fungi. Results showed that this gel wash is a mild, moisturizing cleanser that maintains the natural pH and microbial diversity of vulvar skin. To our knowledge, this was the first study to assess the effect of an antimicrobial feminine gel wash on the natural pH and vulvar microbiome habitat of the skin using bacterial 16S rRNA and fungal ITS genetic sequencing techniques.
Highlights
Intimate hygiene products are widely used by women as part of their daily cleansing routine; there is a lack of scientific literature about the impact of intimate personal hygiene product use on the vulvar area and even less information is available on the impact on vulvar microbiome stability
Two subjects withdrew after baseline measurement but prior to the Day 14 assessment; their data were only included in the analysis for skin short-term moisturization baseline (T-BL) to T-1 hour, but were excluded from skin tolerance, skin pH and skin microbiome analysis
The objective was to develop a gel wash formulation that provides mild cleansing care and maintains the health of the intimate skin barrier. This was the first study to assess the effect of a feminine gel wash on the natural pH and the vulvar microbiome habitat of the skin using bacterial
Summary
Intimate hygiene products are widely used by women as part of their daily cleansing routine; there is a lack of scientific literature about the impact of intimate personal hygiene product use on the vulvar area and even less information is available on the impact on vulvar microbiome stability. Antibiotics 2020, 9, 55 other skin sites based on many attributes, such as the level of hydration, friction, and permeability [2]. Not much is known about the transitional vulvar skin, which could be considered a combination of moist and sebaceous sites. The natural microflora of the vulva plays a major role in immunity and maintaining vulvovaginal health by creating a low pH environment that is inhospitable to transient or invading organisms from taking foothold. What constitutes a “healthy vulvovaginal microbiome” has not been clearly defined, the concept of dysbiosis is understood as a condition attributed to a microbial imbalance or impaired microbiota where the naturally occurring dominant species are outcompeted by overgrowth of species associated with illness and disorders such as bacterial vaginosis and yeast infection
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