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Trial record 1 of 1 for:    NCT04180748
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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
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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:

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.

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.

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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

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.




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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 :
  1. 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".

  2. 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:
  1. 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.

  2. 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.



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

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
Additional Information:
Publications:

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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