Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04180748
Previous Study | Return to List | Next Study

Survey of the Facial Bacteriome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 21, 2019
First Posted Date November 29, 2019
Last Update Posted Date March 26, 2020
Actual Study Start Date November 25, 2019
Estimated Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 25, 2019)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 25, 2019)
  • 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".
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 25, 2019)
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Survey of the Facial Bacteriome
Official Title Survey of Diversity and Density on the Facial Bacteriome of Different Skin Types
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study population will consist of healthy volunteers with no existing or recent skin conditions.
Condition
  • Understanding Skin Health and the Microbiome
  • Microbial Colonization
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.
Study Groups/Cohorts
  • Normal skin
    Intervention: Other: fluorescence imaging with 405nm light
  • Oily skin
    Intervention: Other: fluorescence imaging with 405nm light
  • Dry skin
    Intervention: Other: fluorescence imaging with 405nm light
  • Combination skin
    Intervention: Other: fluorescence imaging with 405nm light
  • Sensitive skin
    Intervention: Other: fluorescence imaging with 405nm light
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 25, 2019)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 15, 2020
Estimated Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Cristiana O'Brien 4166348754 cristiana.obrien@uhnresearch.ca
Contact: Sara Rapic sara.rapic@uhnresearch.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT04180748
Other Study ID Numbers 19-5749
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Responsible Party University Health Network, Toronto
Study Sponsor University Health Network, Toronto
Collaborators Not Provided
Investigators Not Provided
PRS Account University Health Network, Toronto
Verification Date November 2019