Understanding Skin Health and the MicrobiomeNCT04180748
Survey of the Facial Bacteriome
An observational study of Understanding Skin Health and the Microbiome and Microbial Colonization, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Understanding Skin Health and the Microbiome, Microbial Colonization
- What is being tested?
- fluorescence imaging with 405nm light
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 25 Nov 2019to 20 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of healthy volunteers with no existing or recent skin conditions.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Survey of Diversity and Density on the Facial Bacteriome of Different Skin Types
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.
Read the 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.
- Being tested
- fluorescence imaging with 405nm light
- Keywords
- Microbiome, Dermatology, Cosmetics, Autofluorescence
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorescence imaging with 405nm lightOther
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 group | Role | What they receive |
|---|---|---|
| Normal skin | Not described Receives: Other: fluorescence imaging with 405nm light | |
| Oily skin | Not described Receives: Other: fluorescence imaging with 405nm light | |
| Dry skin | Not described Receives: Other: fluorescence imaging with 405nm light | |
| Combination skin | Not described Receives: Other: fluorescence imaging with 405nm light | |
| Sensitive skin | Not described Receives: Other: fluorescence imaging with 405nm light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: February 2020
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).
Measured: February 2020
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.
Measured: February 2020
Secondary outcomes (2)
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".
Measured: February 2020
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".
Measured: February 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start25 Nov 2019
- Primary completion20 Mar 2021
- Study completion20 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Understanding Skin Health and the MicrobiomeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180748
- Sponsor's protocol ID
- 19-5749
- Status last verified
- Mar 2021
- First submitted
- 21 Nov 2019
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD which underlie results may be shared in an academic publication. It is undecided if these results may yield a publication.
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, Dore 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.
PubMed 20203603Luckey TD. Introduction to intestinal microecology. Am J Clin Nutr. 1972 Dec;25(12):1292-4. doi: 10.1093/ajcn/25.12.1292. No abstract available.
PubMed 4639749Sender 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.
PubMed 27541692Burne RA, Quivey RG Jr, Marquis RE. Physiologic homeostasis and stress responses in oral biofilms. Methods Enzymol. 1999;310:441-60. doi: 10.1016/s0076-6879(99)10035-1.
PubMed 10547811Robinson CJ, Bohannan BJ, Young VB. From structure to function: the ecology of host-associated microbial communities. Microbiol Mol Biol Rev. 2010 Sep;74(3):453-76. doi: 10.1128/MMBR.00014-10.
PubMed 20805407Davey ME, O'toole GA. Microbial biofilms: from ecology to molecular genetics. Microbiol Mol Biol Rev. 2000 Dec;64(4):847-67. doi: 10.1128/MMBR.64.4.847-867.2000.
PubMed 11104821Salem 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.
PubMed 30042740Prescott 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.
PubMed 28855974Lee 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.
PubMed 29193830Sohn E. Skin microbiota's community effort. Nature. 2018 Nov;563(7732):S91-S93. doi: 10.1038/d41586-018-07432-8. No abstract available.
PubMed 30464283Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.
PubMed 3377516Stone FM, Coulter CB. PORPHYRIN COMPOUNDS DERIVED FROM BACTERIA. J Gen Physiol. 1932 Jul 20;15(6):629-39. doi: 10.1085/jgp.15.6.629.
PubMed 19872672Philipp-Dormston WK, Doss M. Comparison of porphyrin and heme biosynthesis in various heterotrophic bacteria. Enzyme. 1973;16(1):57-64. doi: 10.1159/000459362. No abstract available.
PubMed 4208581Kjeldstad B, Christensen T, Johnsson A. Porphyrin photosensitization of bacteria. Adv Exp Med Biol. 1985;193:155-9. doi: 10.1007/978-1-4613-2165-1_18. No abstract available.
PubMed 4096295Cox CD, Adams P. Siderophore activity of pyoverdin for Pseudomonas aeruginosa. Infect Immun. 1985 Apr;48(1):130-8. doi: 10.1128/iai.48.1.130-138.1985.
PubMed 3156815
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Diversity and Density on the Facial Bacteriome of Different Skin Types
- ClinicalTrials.gov ID
- NCT04180748
- Acronym / sponsor ID
- 19-5749
- Keywords
- Microbiome, Dermatology, Cosmetics, Autofluorescence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 29 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Normal skin | – | Other: fluorescence imaging with 405nm light |
| Oily skin | – | Other: fluorescence imaging with 405nm light |
| Dry skin | – | Other: fluorescence imaging with 405nm light |
| Combination skin | – | Other: fluorescence imaging with 405nm light |
| Sensitive skin | – | Other: fluorescence imaging with 405nm light |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of healthy volunteers with no existing or recent skin conditions.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluorescence imaging with 405nm lightEach 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. | Other | Combination skin, Dry skin, Normal skin, Oily skin, Sensitive skin |
Primary outcome
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.
2 secondary outcomes
Identification of spatial distribution of bacterial species (CFU/cm2 of individual species)
Time frame: February 2020
Identification of spatial distribution of red/green fluorescence detected with MolecuLight i:X™ (red and green fluroescence/cm2)
Time frame: February 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Background: PubMed 20203603Qin 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, Dore 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.
- Background: PubMed 4639749Luckey TD. Introduction to intestinal microecology. Am J Clin Nutr. 1972 Dec;25(12):1292-4. doi: 10.1093/ajcn/25.12.1292. No abstract available.
- Background: PubMed 27541692Sender 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.
- Background: PubMed 10547811Burne RA, Quivey RG Jr, Marquis RE. Physiologic homeostasis and stress responses in oral biofilms. Methods Enzymol. 1999;310:441-60. doi: 10.1016/s0076-6879(99)10035-1.
- Background: PubMed 20805407Robinson CJ, Bohannan BJ, Young VB. From structure to function: the ecology of host-associated microbial communities. Microbiol Mol Biol Rev. 2010 Sep;74(3):453-76. doi: 10.1128/MMBR.00014-10.
- Background: PubMed 11104821Davey ME, O'toole GA. Microbial biofilms: from ecology to molecular genetics. Microbiol Mol Biol Rev. 2000 Dec;64(4):847-67. doi: 10.1128/MMBR.64.4.847-867.2000.
- Background: PubMed 30042740Salem 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.
- Background: PubMed 28855974Prescott 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.
- Background: PubMed 29193830Lee 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.
- Background: PubMed 30464283Sohn E. Skin microbiota's community effort. Nature. 2018 Nov;563(7732):S91-S93. doi: 10.1038/d41586-018-07432-8. No abstract available.
- Background: PubMed 3377516Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.
- Background: PubMed 19872672Stone FM, Coulter CB. PORPHYRIN COMPOUNDS DERIVED FROM BACTERIA. J Gen Physiol. 1932 Jul 20;15(6):629-39. doi: 10.1085/jgp.15.6.629.
- Understanding Your Skin. Different skin conditions as defined by cosmetic industryLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. IPD which underlie results may be shared in an academic publication. It is undecided if these results may yield a publication.
Related trials for Understanding Skin Health and the Microbiome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Understanding Skin Health and the Microbiome and Microbial Colonization, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial diversity between individuals of each skin condition (i.e. normal, dry, oily, combination, sensitive). (Number of CFU) (time frame: February 2020). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04180748, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.