Survey of the Facial Bacteriome

Microbial Colonization Clinical Trial

Official title:

Survey of Diversity and Density on the Facial Bacteriome of Different Skin Types

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04180748
• Other study ID #: 19-5749
• Status: Completed
• Start date: November 25, 2019
• Est. completion date: March 20, 2021

Study information

• Verified date: March 2021
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 20, 2021
• Est. primary completion date: March 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Microbial Colonization
• Understanding Skin Health and the Microbiome

Intervention

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.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Research Tower	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Imapact of cosmetic use on diversity of bacterial species across individuals with different cosmetic use (high, mid, low). (Number of CFU)	Compare the frequency of specific bacterial species and bacterial families identified with microbiology and microbiome techniques between individuals with different skin care routines.	February 2020
Other	Imapact of cosmetic use on density of bacterial species across individuals with different cosmetic use (high, mid, low). (CFU/cm2)	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.	February 2020
Primary	Bacterial diversity between individuals of each skin condition (i.e. normal, dry, oily, combination, sensitive). (Number of CFU)	Frequency of unique colonies identified from microbiological and microbiome techniques between individuals of each skin condition (i.e. normal, dry, oily, combination, sensitive).	February 2020
Primary	Bacterial density (CFU/cm2) between individuals of each skin condition	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).	February 2020
Primary	MolecuLight i:X detection of density and diversity (green or red fluroescence/cm2)	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.	February 2020
Secondary	Identification of spatial distribution of bacterial species (CFU/cm2 of individual species)	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".	February 2020
Secondary	Identification of spatial distribution of red/green fluorescence detected with MolecuLight i:X™ (red and green fluroescence/cm2)	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".	February 2020

External Links

•   Understanding Your Skin. Different skin conditions as defined by cosmetic industry