The Effect of Skin Cleansers on the Skin Surface Microbiome

February 26, 2018 updated by: Mundipharma Manufacturing Pte Ltd.
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore, 119074
        • National University Hospital Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female subjects between age 21 to 65 years
  • Must wear short sleeved shirts/blouses during each visit
  • Non-smoker
  • Good general and mental health with, in the opinion of investigator or the qualified medical designee:

    1. No clinically significant and relevant abnormalities of medical history or physical examination;
    2. Absence of any condition that would impact the subject's safety or health or affect the subject's ability to understand and comply with the study procedures.
  • Prepared to use the provided wash products that do not contain any antimicrobials (non antibacterial shampoo [Pantene® Pro-V], non antibacterial body wash [Dove®body wash] and non antibacterial hand wash [Guardian gel hand wash]) after providing consent and during the whole study
  • Healthy and intact skin in the test area (e.g., no skin allergy, visible bleeding, skin inflammation, skin ulcer or skin lesion, no need for cutaneous treatment)
  • Must have given written informed consent
  • Women of child-bearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.

Exclusion Criteria:

  • Women who are pregnant or have a positive urine pregnancy test or intending to become pregnant during the overall study period
  • Women who are breast-feeding
  • Allergy or contraindication to any test product substance (active or excipients)
  • Any visible signs of skin dermatitis on the hands, e.g., eczema
  • Use of anti-dandruff shampoo or any other shampoo/hand/body wash products apart from those provided, within 2 days prior to Visit 2 (Day 0) and also during the whole study
  • Systemic or topical or oral antibiotic or antifungal in the past 2 months before Screening and during the study
  • Medication use (e.g., lithium therapy, immunosuppressive medication, systemic or inhaled glucocorticoids) in the past 2 months before Screening and during the study
  • Recent history (within the last 1 year) of alcohol or other substance abuse
  • Known hyperthyroidism or other ongoing thyroid diseases
  • Minor ailments such as like cough, cold, upper respiratory tract infection(s) within 2 weeks and during the study
  • Any known serious ongoing disease
  • Unwillingness or inability to comply with the requirements of the protocol
  • Participation in any other drug, biologic, device, or clinical study or treatment with any investigational drug or approved therapy for investigational use within 30 days (or 5 half-lives, whichever is longer) before Screening
  • An employee of the sponsor or study site or their immediate family member
  • Subject who has been treated with cancer within the last 1 year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment sequence Group 1

Treatment Sequence Group 1 = A -> B -> C

Treatment A = Betadine® 7.5% skin cleanser (PVP-I 7.5%)

Treatment B = 4% chlorhexidine skin cleanser - Unity antiseptic hand wash (no alcohol)

Treatment C = Plain non antibacterial soap - Guardian gel hand wash (not medicated)

Betadine® 7.5% skin cleanser (PVP-I 7.5%)
Unity antiseptic hand wash (no alcohol)
Guardian gel hand wash (not medicated),
Active Comparator: Treatment sequence Group 2

Treatment Sequence Group 2 = B -> C -> A

Treatment B = 4% chlorhexidine skin cleanser - Unity antiseptic hand wash (no alcohol)

Treatment C = Plain non antibacterial soap - Guardian gel hand wash (not medicated)

Treatment A = Betadine® 7.5% skin cleanser (PVP-I 7.5%)

Betadine® 7.5% skin cleanser (PVP-I 7.5%)
Unity antiseptic hand wash (no alcohol)
Guardian gel hand wash (not medicated),
Active Comparator: Treatment sequence Group 3

Treatment Sequence Group 3 = C -> A ->B

Treatment C = Plain non antibacterial soap - Guardian gel hand wash (not medicated)

Treatment A = Betadine® 7.5% skin cleanser (PVP-I 7.5%)

Treatment B = 4% chlorhexidine skin cleanser - Unity antiseptic hand wash (no alcohol)

Betadine® 7.5% skin cleanser (PVP-I 7.5%)
Unity antiseptic hand wash (no alcohol)
Guardian gel hand wash (not medicated),

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composition of skin microbiome - reduction of microflora amount
Time Frame: [Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]
The change in amount of skin microflora species composition from baseline after the usage of a single application of different skin cleansers using next generation sequencing (NGS) and real-time PCR techniques at 3 mins and 240 mins.
[Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]
Composition of skin microbiome - maintenance of healthy microflora amount
Time Frame: [Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]
The change in amount of healthy skin microflora species composition from baseline after the usage of a single application of different skin cleansers using next generation sequencing (NGS) and real-time PCR techniques at 3 mins and 240 mins.
[Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]
Composition of skin microbiome - reduction of microflora variety
Time Frame: [Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]
The change in variety of skin microflora species composition from baseline after the usage of a single application of different skin cleansers using next generation sequencing (NGS) and real-time PCR techniques at 3 mins and 240 mins.
[Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]
Composition of skin microbiome - maintenance of healthy microflora variety
Time Frame: [Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]
The change in variety of healthy skin microflora species composition from baseline after the usage of a single application of different skin cleansers using next generation sequencing (NGS) and real-time PCR techniques at 3 mins and 240 mins.
[Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nisha Su Yien Subash Chandran, National University Hospital, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2017

Primary Completion (Actual)

January 26, 2018

Study Completion (Actual)

January 26, 2018

Study Registration Dates

First Submitted

November 16, 2017

First Submitted That Met QC Criteria

November 16, 2017

First Posted (Actual)

November 21, 2017

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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