A 28 Day Clinical Assessment of a Lactic Acid-containing Antimicrobial Intimate Gel Wash Formulation on Skin Tolerance and Impact on the Vulvar Microbiome.

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.

Virucidal efficacy of disinfectant actives against feline calicivirus, a surrogate for norovirus, in a short contact time.

BACKGROUND: Among other measures, handwashing and targeted disinfection are important in preventing and controlling norovirus outbreaks. Presently, there are a limited number of disinfectants effective against norovirus. There is a need to develop alternatives to bleach that are effective against norovirus, and, in particular, fast-acting disinfectants are desired. The aim of this study was to determine the disinfectant actives and formulation factors necessary to achieve efficacy against norovirus in a short contact time. METHODS: Feline calicivirus (FCV) was used as a surrogate for norovirus. In a carrier test method, common disinfectant actives including alcohol, acid, quaternary compound, and phenol both alone and as formulated disinfectants were contacted with dried FCV virus for 1 minute. The virus treatment was neutralized and assayed in Crandell-Reese kidney cells for cytopathic effect. Log(10) virus inactivation was calculated comparing treatment results to virus control titer. RESULTS: Bleach and acid-based disinfectants inactivate FCV in 1 minute. Inactivation of FCV by alcohol and quaternary actives depends on how these actives are formulated as disinfectants. Actives and extreme pH are determined predictive of efficacy. Ethanol and quaternary compounds formulated at appropriate concentration and alkaline pH inactivates FCV in 1-minute contact. CONCLUSION: Acid cleaners, ethanol, and quaternary compounds formulated at appropriate concentration and pH can be fast-acting antimicrobial choices and alternatives to bleach for the consumer and health care providers to use to inactivate FCV, a surrogate for norovirus, and protect against this important pathogen.