Survey of the Facial Bacteriome

Completed

• Conditions: Microbial Colonization; Understanding Skin Health and the Microbiome
• Interventions: Other: fluorescence imaging with 405nm light

• Registration Number: NCT04180748
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2019-11-21
• Study Start: 2019-11-25
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-29
• Status Verified: 2021-03
• Primary Completion: 2021-03-20
• Study Completion: 2021-03-20
• Last Update Submitted: 2021-03-26
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oily skin	fluorescence imaging with 405nm light	-
Combination skin	fluorescence imaging with 405nm light	-
Normal skin	fluorescence imaging with 405nm light	-
Dry skin	fluorescence imaging with 405nm light	-
Sensitive skin	fluorescence imaging with 405nm light	-

Primary Outcome Measures

Name	Time	Method
Bacterial diversity between individuals of each skin condition (i.e. normal, dry, oily, combination, sensitive). (Number of CFU)	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).
MolecuLight i:X detection of density and diversity (green or red fluroescence/cm2)	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.
Bacterial density (CFU/cm2) between individuals of each skin condition	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).

Secondary Outcome Measures

Name	Time	Method
Identification of spatial distribution of bacterial species (CFU/cm2 of individual species)	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)	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".

Trial Locations

Locations (1)

Princess Margaret Cancer Research Tower; 🇨🇦 Toronto, Ontario, Canada