NCT03348917

The Effect of Skin Cleansers on the Skin Surface Microbiome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Mundipharma Manufacturing Pte Ltd. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Skin Health

Interventions

Type	Name	Description
DRUG	7.5% Povidone-Iodine [PVP-I]	Betadine® 7.5% skin cleanser (PVP-I 7.5%)
DRUG	4% chlorhexidine skin cleanser	Unity antiseptic hand wash (no alcohol)
DRUG	Plain non antibacterial soap	Guardian gel hand wash (not medicated),

Timeline

• Start date: 2017-12-28
• Primary completion: 2018-01-26
• Completion: 2018-01-26
• First posted: 2017-11-21
• Last updated: 2018-02-28

Locations

1 site across 1 country: Singapore