Survey of the Facial Bacteriome

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ClinicalTrials.gov Identifier: NCT04180748

Recruitment Status : Recruiting

First Posted : November 29, 2019

Last Update Posted : March 26, 2020

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Sponsor:

Information provided by (Responsible Party):

University Health Network, Toronto

Study Description

Brief Summary:

The microbiome can affect skin health from the gut-skin axis, from environmental exposure, and topical treatments. Decreasing biodiversity of skin microbiota has been linked to inflammatory conditions, allergies, and skin health.

This cross sectional study will be used to survey healthy volunteers and measure the density and diversity of skin flora of varying skin types. The aim of this study is to identify associations between the skin flora and characteristics of healthy skin types.

Condition or disease	Intervention/treatment
Understanding Skin Health and the Microbiome Microbial Colonization	Other: fluorescence imaging with 405nm light

Detailed Description:

Therefore, this cross sectional study will be used to survey healthy volunteers and measure the density and diversity of skin flora of varying skin types.

This study will aim to determine if there are associations between the diversity and/or density of normal bacterial flora and (1) the different skin types (i.e. normal, dry, oily, combination, sensitive); (2) the different Fitzpatrick skin types (i.e. ivory; fair or pale; fair to beige with golden undertones; olive or light brown; dark brown; deeply pigmented dark brown to darkest brown): (3) the number of skin products used daily representing time spent on skin health (i.e. low:0-1, mid:2-4, high:5+). Participants will complete a survey in which they will identify their skin conditions and the number and type of skin products they use on their face as a part of their daily routine.

In addition, this study will evaluate the potential of an autofluorescence image-guided device to capture differences in healthy human skin flora through autofluorescence. The MolecuLight i:X™ is used to detect bacteria in chronic wounds. Based on extensive preclinical and clinical studies, the i:X has demonstrated its capability at collecting autofluorescent images of wounds and detecting the presence and relative changes in connective tissue (e.g. collagen) content and bio-distribution involved in wound healing. It can also detect the presence and relative amounts of commensal and pathogenic bacteria within the wound based on autofluorescence alone (these bacteria are invisible to standard visualization with the naked eye using white light), thus providing a measure of infection status.

The imaging device will be used to image skin from the cheek and forehead of healthy volunteers to compare the fluorescent characteristics of normal skin flora. The fluorescent images captured with the i:X™ will be compared against 16S RNA analysis of the skin microbiome and traditional microbiology techniques with selective and differential tests. In addition, non-selective agars will be used to grow bacteria according to the spatial topography of the skin, using a tape stripping method, with lightly adhesive 3M™Tegaderm wound dressings. This will serve as a "map" for fluorescent images by which to compare fluorescent features to bacterial species.

Study Design

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Study Type :	Observational
Estimated Enrollment :	30 participants
Observational Model:	Other
Time Perspective:	Prospective
Official Title:	Survey of Diversity and Density on the Facial Bacteriome of Different Skin Types
Actual Study Start Date :	November 25, 2019
Estimated Primary Completion Date :	May 15, 2020
Estimated Study Completion Date :	June 15, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
Normal skin	Other: fluorescence imaging with 405nm light Each group will have images taken with an Health Canada approved device to capture images under white light and 405nm fluorescence with an mCherry filter. These images will not be used for diagnostics and will be analyzed for features which correlate to identified microbes from 16S RNA analysis and traditional microbiological technique. Groups are self identified by participants in order to capture a diverse population.
Oily skin	Other: fluorescence imaging with 405nm light Each group will have images taken with an Health Canada approved device to capture images under white light and 405nm fluorescence with an mCherry filter. These images will not be used for diagnostics and will be analyzed for features which correlate to identified microbes from 16S RNA analysis and traditional microbiological technique. Groups are self identified by participants in order to capture a diverse population.
Dry skin	Other: fluorescence imaging with 405nm light Each group will have images taken with an Health Canada approved device to capture images under white light and 405nm fluorescence with an mCherry filter. These images will not be used for diagnostics and will be analyzed for features which correlate to identified microbes from 16S RNA analysis and traditional microbiological technique. Groups are self identified by participants in order to capture a diverse population.
Combination skin	Other: fluorescence imaging with 405nm light Each group will have images taken with an Health Canada approved device to capture images under white light and 405nm fluorescence with an mCherry filter. These images will not be used for diagnostics and will be analyzed for features which correlate to identified microbes from 16S RNA analysis and traditional microbiological technique. Groups are self identified by participants in order to capture a diverse population.
Sensitive skin	Other: fluorescence imaging with 405nm light Each group will have images taken with an Health Canada approved device to capture images under white light and 405nm fluorescence with an mCherry filter. These images will not be used for diagnostics and will be analyzed for features which correlate to identified microbes from 16S RNA analysis and traditional microbiological technique. Groups are self identified by participants in order to capture a diverse population.

Outcome Measures

Primary Outcome Measures :

Bacterial diversity between individuals of each skin condition (i.e. normal, dry, oily, combination, sensitive). (Number of CFU) [ Time Frame: February 2020 ]
Frequency of unique colonies identified from microbiological and microbiome techniques between individuals of each skin condition (i.e. normal, dry, oily, combination, sensitive).
Bacterial density (CFU/cm2) between individuals of each skin condition [ Time Frame: February 2020 ]
Abundance of bacterial colonies per cm2 of sampled area identified from microbiological and microbiome techniques between individuals of each skin condition (i.e. normal, dry, oily, combination, sensitive).
MolecuLight i:X detection of density and diversity (green or red fluroescence/cm2) [ Time Frame: February 2020 ]
Abundance of green and/or red fluorescent detection with MolecuLight i:X per cm2 of sampled area between individuals of each skin condition. Frequency of green or red fluorescence per sample.

Secondary Outcome Measures :

Identification of spatial distribution of bacterial species (CFU/cm2 of individual species) [ Time Frame: February 2020 ]
Abundance of unique species and bacterial families identified from microbiological and microbiome techniques between individuals of each skin condition (i.e. normal, dry, oily, combination, sensitive) and Fitzpatrick skin type per. Distribution of unique species and bacterial families across the area of sampling of individuals on Tegaderm "map".
Identification of spatial distribution of red/green fluorescence detected with MolecuLight i:X™ (red and green fluroescence/cm2) [ Time Frame: February 2020 ]
Abundance of unique fluorescent (green and red) detection with MolecuLight i:X™ between individuals of each skin condition (i.e. normal, dry, oily, combination, sensitive) and Fitzpatrick skin type. Distribution of red and green fluorescent signals across the area of sampling of individuals on Tegaderm "map".

Other Outcome Measures:

Imapact of cosmetic use on diversity of bacterial species across individuals with different cosmetic use (high, mid, low). (Number of CFU) [ Time Frame: February 2020 ]
Compare the frequency of specific bacterial species and bacterial families identified with microbiology and microbiome techniques between individuals with different skin care routines.
Imapact of cosmetic use on density of bacterial species across individuals with different cosmetic use (high, mid, low). (CFU/cm2) [ Time Frame: February 2020 ]
Compare the abundance of specific bacterial species and bacterial families identified with microbiology and microbiome techniques between individuals with different skin care routines per cm2 of area sampled.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

The study population will consist of healthy volunteers with no existing or recent skin conditions.

Criteria

Inclusion Criteria:

Healthy male or female 18 years or older.
Able to provide consent
Identifies as having normal (n=6), oily (n=6), dry (n=6), combination (n=6), and/or sensitive (n=6) skin groups.

Exclusion Criteria:

Treatment with topical or oral antibiotic(s) or antifungal(s) within 1 month of enrolment
Diagnosed with chronic conditions (excluding acne and dermatological conditions)
Treatment for a chronic condition
Diagnosed with bacterial/fungal infection within 1 month of enrolment
Treatment with an investigational drug within 1 month of enrolment
Allergies to antibiotics, antiseptics, tape, or adhesives
Inability to consent

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04180748

Contacts

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Contact: Cristiana O'Brien	4166348754	cristiana.obrien@uhnresearch.ca
Contact: Sara Rapic		sara.rapic@uhnresearch.ca

Locations

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Canada, Ontario
Princess Margaret Cancer Research Tower	Recruiting
Toronto, Ontario, Canada, M5G1L7
Contact: Cristiana O'Brien 4166348754 cristiana.obrien@uhnresearch.ca
Contact: Sara Rapic sara.rapic@uhnresearch.ca

Sponsors and Collaborators

University Health Network, Toronto

More Information

Additional Information:

Understanding Your Skin. Different skin conditions as defined by cosmetic industry This link exits the ClinicalTrials.gov site

Publications:

Qin J, Li R, Raes J, Arumugam M, Burgdorf KS, Manichanh C, Nielsen T, Pons N, Levenez F, Yamada T, Mende DR, Li J, Xu J, Li S, Li D, Cao J, Wang B, Liang H, Zheng H, Xie Y, Tap J, Lepage P, Bertalan M, Batto JM, Hansen T, Le Paslier D, Linneberg A, Nielsen HB, Pelletier E, Renault P, Sicheritz-Ponten T, Turner K, Zhu H, Yu C, Li S, Jian M, Zhou Y, Li Y, Zhang X, Li S, Qin N, Yang H, Wang J, Brunak S, Doré J, Guarner F, Kristiansen K, Pedersen O, Parkhill J, Weissenbach J; MetaHIT Consortium, Bork P, Ehrlich SD, Wang J. A human gut microbial gene catalogue established by metagenomic sequencing. Nature. 2010 Mar 4;464(7285):59-65. doi: 10.1038/nature08821.

Luckey TD. Introduction to intestinal microecology. Am J Clin Nutr. 1972 Dec;25(12):1292-4.

Sender R, Fuchs S, Milo R. Revised Estimates for the Number of Human and Bacteria Cells in the Body. PLoS Biol. 2016 Aug 19;14(8):e1002533. doi: 10.1371/journal.pbio.1002533. eCollection 2016 Aug.

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Davey ME, O'toole GA. Microbial biofilms: from ecology to molecular genetics. Microbiol Mol Biol Rev. 2000 Dec;64(4):847-67. Review.

Salem I, Ramser A, Isham N, Ghannoum MA. The Gut Microbiome as a Major Regulator of the Gut-Skin Axis. Front Microbiol. 2018 Jul 10;9:1459. doi: 10.3389/fmicb.2018.01459. eCollection 2018. Review.

Prescott SL, Larcombe DL, Logan AC, West C, Burks W, Caraballo L, Levin M, Etten EV, Horwitz P, Kozyrskyj A, Campbell DE. The skin microbiome: impact of modern environments on skin ecology, barrier integrity, and systemic immune programming. World Allergy Organ J. 2017 Aug 22;10(1):29. doi: 10.1186/s40413-017-0160-5. eCollection 2017. Review.

Lee HJ, Jeong SE, Lee S, Kim S, Han H, Jeon CO. Effects of cosmetics on the skin microbiome of facial cheeks with different hydration levels. Microbiologyopen. 2018 Apr;7(2):e00557. doi: 10.1002/mbo3.557. Epub 2017 Nov 29.

Sohn E. Skin microbiota's community effort. Nature. 2018 Nov;563(7732):S91-S93. doi: 10.1038/d41586-018-07432-8.

Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71.

Stone FM, Coulter CB. PORPHYRIN COMPOUNDS DERIVED FROM BACTERIA. J Gen Physiol. 1932 Jul 20;15(6):629-39.

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Agren MS, Werthén M. The extracellular matrix in wound healing: a closer look at therapeutics for chronic wounds. Int J Low Extrem Wounds. 2007 Jun;6(2):82-97. Review.

DaCosta RS, Kulbatski I, Lindvere-Teene L, Starr D, Blackmore K, Silver JI, Opoku J, Wu YC, Medeiros PJ, Xu W, Xu L, Wilson BC, Rosen C, Linden R. Point-of-care autofluorescence imaging for real-time sampling and treatment guidance of bioburden in chronic wounds: first-in-human results. PLoS One. 2015 Mar 19;10(3):e0116623. doi: 10.1371/journal.pone.0116623. eCollection 2015.

Wu YC, Kulbatski I, Medeiros PJ, Maeda A, Bu J, Xu L, Chen Y, DaCosta RS. Autofluorescence imaging device for real-time detection and tracking of pathogenic bacteria in a mouse skin wound model: preclinical feasibility studies. J Biomed Opt. 2014 Aug;19(8):085002. doi: 10.1117/1.JBO.19.8.085002.

He SY, McCulloch CE, Boscardin WJ, Chren MM, Linos E, Arron ST. Self-reported pigmentary phenotypes and race are significant but incomplete predictors of Fitzpatrick skin phototype in an ethnically diverse population. J Am Acad Dermatol. 2014 Oct;71(4):731-7. doi: 10.1016/j.jaad.2014.05.023. Epub 2014 Jun 11.

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Chamma E, Qiu J, Lindvere-Teene L, Blackmore KM, Majeed S, Weersink R, Dickie CI, Griffin AM, Wunder JS, Ferguson PC, DaCosta RS. Optically-tracked handheld fluorescence imaging platform for monitoring skin response in the management of soft tissue sarcoma. J Biomed Opt. 2015 Jul;20(7):076011. doi: 10.1117/1.JBO.20.7.076011.

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Responsible Party:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT04180748
Other Study ID Numbers:	19-5749
First Posted:	November 29, 2019 Key Record Dates
Last Update Posted:	March 26, 2020
Last Verified:	November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	IPD which underlie results may be shared in an academic publication. It is undecided if these results may yield a publication.

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by University Health Network, Toronto:


Microbiome Dermatology Cosmetics Autofluorescence

Additional relevant MeSH terms:

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Communicable Diseases Infection

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