Skin Health Clinical Trial
Official title:
The Effect of Skin Cleansers on the Skin Surface Microbiome
This study determines the effects of a single application of different antiseptic skin cleansers on the composition of the skin surface microbiome using next-generation sequencing (NGS) techniques. Twelve healthy volunteers will receive all three test products in a randomized order to compare the effects of each skin cleanser.
Disinfectants and oral antiseptics including PVP-I are known to kill microorganisms to a
variable extent, at a variable range of time points. Microorganisms may be protected from
disinfectants by production of thick masses of cells and extracellular materials, or
biofilms. Moreover, antiseptics should not lead to dysbiosis after use. Dysbiosis is a
negative change in the microbiome of a particular skin or mucosal region. The Human
Microbiome project showed, that every area has a specific microbiota in which the human host
lives with an abundance of commensal, synergistic, and potentially pathogenic microorganisms.
Antiseptics with efficacy gaps and resistance may induce such dysbiosis, especially after
prolonged use. It is envisaged that twelve healthy volunteers will complete the study. Each
healthy volunteer will apply the test product according to a developed protocol, between
established wash out periods.
The ability of the test product (Commercially available - Betadine® 7.5% skin cleanser (PVP-I
7.5%)) compared to the reference products (commercially available 4% chlorhexidine skin
cleanser - Unity antiseptic hand wash (no alcohol) and Plain non antibacterial soap -
Guardian gel hand wash (not medicated)) to reduce resident and transient microflora will be
assessed. The hand wash products will also be assessed for their ability to maintain and/or
restore balanced microflora.
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