Microbial DiseaseFoot-skin M&MNCT04781036
Foot-skin Microbiome and Metabolomics of Pitted Keratolysis
A study testing 4%Chlorhexidine in people with Microbial Disease and Metabolomics, run by Mahidol University at 2 sites in Thailand.
Trial summary
This study aimed to investigate the skin microbiome and metabolomics of patients with pitted keratolysis. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Microbial Disease, Metabolomics
- What is being tested?
- 4%Chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesThailand
- Study dates
- 1 May 2023to 1 Dec 2024
- Phase
- Interventional
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Naval rating cadets at Chumpol Naval Rating School, Thailand who volunteer to participate in this study. Informed consent will be obtained from all participants.
- Age ≥ 18 years.
- No underlying disease.
- Normal BMI (18.5-22.9 kg/m2).
- No previous history of pitted keratolysis.
- No previous history of dermatophytosis complex.
- Refrain from washing their feet for 12 hours prior to sampling.
Who cannot join
- Volunteers who have taken medication or topical antibiotics for pitted keratolysis within 2 weeks before the enrollment.
- Volunteers who have taken oral antibiotics within 2 weeks before enrollment.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Department of Dermatology Siriraj Hospital
Bangkok, 10700
Department of Dermatology Siriraj Hospital
Bangkoknoi, Bangkok, 10700
About this study
Official title: The Study of Foot-skin Microbiome and Metabolomics of Thai Naval Cadets With Pitted Keratolysis
This study aimed to investigate the skin microbiome and metabolomics of patients with pitted keratolysis.
Read the detailed description
Pitted keratolysis is a skin infectious disease which can cause an unpleasant smell that can affect self-confidence and interpersonal relationships. The research problem was initiated through a community outreach program organized by the Department of Dermatology Siriraj Hospital, Thailand. From many years of experiences, our dermatologist teams observed that pitted keratolysis was a common disease among naval cadets who wore enclosed footwear for long hours, and it was more prevalent after a boot camp that spanned over months. This disease is chronic with no efficient standard treatment and limited information on the pathogenesis of the disease. Therefore, we propose to conduct a study on the pathogenesis of pitted keratolysis and malodorous feet through a longitudinal study of foot-skin microbiome and associated volatile metabolomic profiles of foot odor. With the unique population, with similar age range, daily activities, and diet, this study will allow to focus on the association of changes in microbiome in relation to pathogenesis of pitted keratolysis and malodorous feet, with fewer cofounding factors.
The skin microbiome is a group of various microorganisms, such as bacteria, fungi, and viruses, residing on skin. Human skin microbiome can differ with respect to age, ethnicity, diet, climate and environment. Recently, there have been numerous studies highlighting the association of microbes with pathogenesis of various skin diseases, such as atopic dermatitis, acne vulgaris, and psoriasis (references?). In this project, we hypothesize that the alteration of skin microbiome as well as changes in metabolite profiles can be associated with the mechanism of the disease. The skin microbiome data generated in this study will be analyzed for microbial profiles using the QIIME2, a next-generation microbiome bioinformatics platform, and a graphic software package, "Statistical Analysis of Taxonomic and Functional Profiles" (STAMP). In parallel, we will apply a high throughput gas chromatography mass-spectrometry-based metabolomics to detect volatile metabolites present in foot odor in association with the observed foot-skin microbiome. This metabolite information will not only provide an additional aspect of pathogenesis of the disease but also might offer a new standard indicator of foot odor that can be further used in clinical practice. Finally, skin microbiome and metabolomic data will be analyzed using various methods of correlation analysis as well as integrative analysis to gain deeper understanding of the disease mechanism at the molecular levels.
The outcomes of this project will provide insights into the pathogenesis of pitted keratolysis. The scientific knowledge gained from the study will be translated into a more effective treatment of the disease. The human microbiome of healthy population and the disease-specific microbiome data will lay the groundwork to develop a human microbiome database for Thai people. Additionally, the success of the project will allow the development of advanced instrumental methodology and an integrative analysis approach to analyze multi -omics data, which will be great assets in advancing multidisciplinary research.
- Conditions
- Microbial Disease, Metabolomics
- Being tested
- 4%Chlorhexidine
- Keywords
- Pitted keratolysis, Microbiome, Metabolomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4%ChlorhexidineDrug
4%Chlorhexidine was given to participants with foot odor for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Normal feet | No intervention | * Swab their feet to analyze foot microbiome via 16s DNA sequencing * Collect their socks to analyze metabolomics via gas chromatography |
| Foot odor without pitted keratolysis | Experimental | * Swab their feet to analyze foot microbiome via 16s DNA sequencing
* Collect their socks to analyze metabolomics via gas chromatography
* Apply 4% chlorhexidine for 2 weeks
* Re-evaluate their feet at time of treatment finish and 1 months after treatment finish. The forementioned methods (swab and collect their socks) will be applied on their feet again.
* The microbiome and metabolomics will be analyzed to evaluate the difference of microbe and substances after treatment. Receives: Drug: 4%Chlorhexidine |
| Foot odor with pitted keratolysis | Experimental | * Swab their feet to analyze foot microbiome via 16s DNA sequencing
* Collect their socks to analyze metabolomics via gas chromatography
* Apply 4% chlorhexidine for 2 weeks
* Re-evaluate their feet at time of treatment finish and 1 months after treatment finish. The forementioned methods (swab and collect their socks) will be applied on their feet again.
* The microbiome and metabolomics will be analyzed to evaluate the difference of microbe and substances after treatment. Receives: Drug: 4%Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of skin microbiome
Foot-skin microbial profiles of healthy Thai people and patients with pitted keratolysis
Measured: 2 months
Composition of microbiota at skin
Foot-skin microbial profiles of healthy Thai people and patients with pitted keratolysis
Measured: 2 months
Secondary outcomes (1)
Amount of metabolite in foot odor
Metabolite profiling of foot odor
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 May 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Microbial DiseaseStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charussri Leeyaphan, Mahidol University
- Investigators
- Sumanas Bunyaratavej, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781036
- Sponsor's protocol ID
- PK microbiome and metabolomic
- Acronym
- Foot-skin M&M
- Status last verified
- Mar 2024
- First submitted
- 25 Feb 2021
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grice EA, Segre JA. The skin microbiome. Nat Rev Microbiol. 2011 Apr;9(4):244-53. doi: 10.1038/nrmicro2537.
PubMed 21407241Musthaq S, Mazuy A, Jakus J. The microbiome in dermatology. Clin Dermatol. 2018 May-Jun;36(3):390-398. doi: 10.1016/j.clindermatol.2018.03.012. Epub 2018 Mar 10.
PubMed 29908581Perez Perez GI, Gao Z, Jourdain R, Ramirez J, Gany F, Clavaud C, Demaude J, Breton L, Blaser MJ. Body Site Is a More Determinant Factor than Human Population Diversity in the Healthy Skin Microbiome. PLoS One. 2016 Apr 18;11(4):e0151990. doi: 10.1371/journal.pone.0151990. eCollection 2016.
PubMed 27088867Sander MA, Sander MS, Isaac-Renton JL, Croxen MA. The Cutaneous Microbiome: Implications for Dermatology Practice. J Cutan Med Surg. 2019 Jul/Aug;23(4):436-441. doi: 10.1177/1203475419839939. Epub 2019 Apr 2.
PubMed 30938174Yu Y, Dunaway S, Champer J, Kim J, Alikhan A. Changing our microbiome: probiotics in dermatology. Br J Dermatol. 2020 Jan;182(1):39-46. doi: 10.1111/bjd.18088. Epub 2019 Jul 28.
PubMed 31049923Szabo K, Erdei L, Bolla BS, Tax G, Biro T, Kemeny L. Factors shaping the composition of the cutaneous microbiota. Br J Dermatol. 2017 Feb;176(2):344-351. doi: 10.1111/bjd.14967. Epub 2017 Jan 23.
PubMed 27518483Schoch JJ, Monir RL, Satcher KG, Harris J, Triplett E, Neu J. The infantile cutaneous microbiome: A review. Pediatr Dermatol. 2019 Sep;36(5):574-580. doi: 10.1111/pde.13870. Epub 2019 Jul 23.
PubMed 31332846Iebba V, Totino V, Gagliardi A, Santangelo F, Cacciotti F, Trancassini M, Mancini C, Cicerone C, Corazziari E, Pantanella F, Schippa S. Eubiosis and dysbiosis: the two sides of the microbiota. New Microbiol. 2016 Jan;39(1):1-12.
PubMed 26922981Thomas CL, Fernandez-Penas P. The microbiome and atopic eczema: More than skin deep. Australas J Dermatol. 2017 Feb;58(1):18-24. doi: 10.1111/ajd.12435. Epub 2016 Jan 28.
PubMed 26821151Holmes E, Wilson ID, Nicholson JK. Metabolic phenotyping in health and disease. Cell. 2008 Sep 5;134(5):714-7. doi: 10.1016/j.cell.2008.08.026.
PubMed 18775301Patti GJ, Yanes O, Siuzdak G. Innovation: Metabolomics: the apogee of the omics trilogy. Nat Rev Mol Cell Biol. 2012 Mar 22;13(4):263-9. doi: 10.1038/nrm3314.
PubMed 22436749Melnik BC. Linking diet to acne metabolomics, inflammation, and comedogenesis: an update. Clin Cosmet Investig Dermatol. 2015 Jul 15;8:371-88. doi: 10.2147/CCID.S69135. eCollection 2015.
PubMed 26203267Nordstrom KM, McGinley KJ, Cappiello L, Zechman JM, Leyden JJ. Pitted keratolysis. The role of Micrococcus sedentarius. Arch Dermatol. 1987 Oct;123(10):1320-5. doi: 10.1001/archderm.123.10.1320.
PubMed 3310909Singh G, Naik CL. Pitted keratolysis. Indian J Dermatol Venereol Leprol. 2005 May-Jun;71(3):213-5. doi: 10.4103/0378-6323.16250. No abstract available.
PubMed 16394424Bolyen E, Rideout JR, Dillon MR, Bokulich NA, Abnet CC, Al-Ghalith GA, Alexander H, Alm EJ, Arumugam M, Asnicar F, Bai Y, Bisanz JE, Bittinger K, Brejnrod A, Brislawn CJ, Brown CT, Callahan BJ, Caraballo-Rodriguez AM, Chase J, Cope EK, Da Silva R, Diener C, Dorrestein PC, Douglas GM, Durall DM, Duvallet C, Edwardson CF, Ernst M, Estaki M, Fouquier J, Gauglitz JM, Gibbons SM, Gibson DL, Gonzalez A, Gorlick K, Guo J, Hillmann B, Holmes S, Holste H, Huttenhower C, Huttley GA, Janssen S, Jarmusch AK, Jiang L, Kaehler BD, Kang KB, Keefe CR, Keim P, Kelley ST, Knights D, Koester I, Kosciolek T, Kreps J, Langille MGI, Lee J, Ley R, Liu YX, Loftfield E, Lozupone C, Maher M, Marotz C, Martin BD, McDonald D, McIver LJ, Melnik AV, Metcalf JL, Morgan SC, Morton JT, Naimey AT, Navas-Molina JA, Nothias LF, Orchanian SB, Pearson T, Peoples SL, Petras D, Preuss ML, Pruesse E, Rasmussen LB, Rivers A, Robeson MS 2nd, Rosenthal P, Segata N, Shaffer M, Shiffer A, Sinha R, Song SJ, Spear JR, Swafford AD, Thompson LR, Torres PJ, Trinh P, Tripathi A, Turnbaugh PJ, Ul-Hasan S, van der Hooft JJJ, Vargas F, Vazquez-Baeza Y, Vogtmann E, von Hippel M, Walters W, Wan Y, Wang M, Warren J, Weber KC, Williamson CHD, Willis AD, Xu ZZ, Zaneveld JR, Zhang Y, Zhu Q, Knight R, Caporaso JG. Author Correction: Reproducible, interactive, scalable and extensible microbiome data science using QIIME 2. Nat Biotechnol. 2019 Sep;37(9):1091. doi: 10.1038/s41587-019-0252-6.
PubMed 31399723
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Foot-skin Microbiome and Metabolomics of Thai Naval Cadets With Pitted Keratolysis
- ClinicalTrials.gov ID
- NCT04781036
- Acronym / sponsor ID
- Foot-skin M&M / PK microbiome and metabolomic
- Conditions
- Microbial Disease, Metabolomics
- Keywords
- Pitted keratolysis, Microbiome, Metabolomics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 4 Mar 2021 (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.
This study aimed to investigate the skin microbiome and metabolomics of patients with pitted keratolysis.
Detailed description
Pitted keratolysis is a skin infectious disease which can cause an unpleasant smell that can affect self-confidence and interpersonal relationships. The research problem was initiated through a community outreach program organized by the Department of Dermatology Siriraj Hospital, Thailand. From many years of experiences, our dermatologist teams observed that pitted keratolysis was a common disease among naval cadets who wore enclosed footwear for long hours, and it was more prevalent after a boot camp that spanned over months. This disease is chronic with no efficient standard treatment and limited information on the pathogenesis of the disease. Therefore, we propose to conduct a study on the pathogenesis of pitted keratolysis and malodorous feet through a longitudinal study of foot-skin microbiome and associated volatile metabolomic profiles of foot odor. With the unique population, with similar age range, daily activities, and diet, this study will allow to focus on the association of changes in microbiome in relation to pathogenesis of pitted keratolysis and malodorous feet, with fewer cofounding factors.
The skin microbiome is a group of various microorganisms, such as bacteria, fungi, and viruses, residing on skin. Human skin microbiome can differ with respect to age, ethnicity, diet, climate and environment. Recently, there have been numerous studies highlighting the association of microbes with pathogenesis of various skin diseases, such as atopic dermatitis, acne vulgaris, and psoriasis (references?). In this project, we hypothesize that the alteration of skin microbiome as well as changes in metabolite profiles can be associated with the mechanism of the disease. The skin microbiome data generated in this study will be analyzed for microbial profiles using the QIIME2, a next-generation microbiome bioinformatics platform, and a graphic software package, "Statistical Analysis of Taxonomic and Functional Profiles" (STAMP). In parallel, we will apply a high throughput gas chromatography mass-spectrometry-based metabolomics to detect volatile metabolites present in foot odor in association with the observed foot-skin microbiome. This metabolite information will not only provide an additional aspect of pathogenesis of the disease but also might offer a new standard indicator of foot odor that can be further used in clinical practice. Finally, skin microbiome and metabolomic data will be analyzed using various methods of correlation analysis as well as integrative analysis to gain deeper understanding of the disease mechanism at the molecular levels.
The outcomes of this project will provide insights into the pathogenesis of pitted keratolysis. The scientific knowledge gained from the study will be translated into a more effective treatment of the disease. The human microbiome of healthy population and the disease-specific microbiome data will lay the groundwork to develop a human microbiome database for Thai people. Additionally, the success of the project will allow the development of advanced instrumental methodology and an integrative analysis approach to analyze multi -omics data, which will be great assets in advancing multidisciplinary research.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal feet | No intervention | –* Swab their feet to analyze foot microbiome via 16s DNA sequencing * Collect their socks to analyze metabolomics via gas chromatography |
| Foot odor without pitted keratolysis | Experimental | Drug: 4%Chlorhexidine* Swab their feet to analyze foot microbiome via 16s DNA sequencing * Collect their socks to analyze metabolomics via gas chromatography * Apply 4% chlorhexidine for 2 weeks * Re-evaluate their feet at time of treatment finish and 1 months after treatment finish. The forementioned methods (swab and collect their socks) will be applied on their feet again. * The microbiome and metabolomics will be analyzed to evaluate the difference of microbe and substances after treatment. |
| Foot odor with pitted keratolysis | Experimental | Drug: 4%Chlorhexidine* Swab their feet to analyze foot microbiome via 16s DNA sequencing * Collect their socks to analyze metabolomics via gas chromatography * Apply 4% chlorhexidine for 2 weeks * Re-evaluate their feet at time of treatment finish and 1 months after treatment finish. The forementioned methods (swab and collect their socks) will be applied on their feet again. * The microbiome and metabolomics will be analyzed to evaluate the difference of microbe and substances after treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Naval rating cadets at Chumpol Naval Rating School, Thailand who volunteer to participate in this study. Informed consent will be obtained from all participants.
- Age ≥ 18 years.
- No underlying disease.
- Normal BMI (18.5-22.9 kg/m2).
- No previous history of pitted keratolysis.
Key exclusion criteria (2 listed)
- Volunteers who have taken medication or topical antibiotics for pitted keratolysis within 2 weeks before the enrollment.
- Volunteers who have taken oral antibiotics within 2 weeks before enrollment.
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 |
|---|---|---|
| 4%Chlorhexidine4%Chlorhexidine was given to participants with foot odor for 2 weeks | Drug | Foot odor with pitted keratolysis, Foot odor without pitted keratolysis |
Primary outcome
Amount of skin microbiome
Time frame: 2 months
Foot-skin microbial profiles of healthy Thai people and patients with pitted keratolysis
Composition of microbiota at skin
Time frame: 2 months
Foot-skin microbial profiles of healthy Thai people and patients with pitted keratolysis
1 secondary outcome
Amount of metabolite in foot odor
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Background: PubMed 21407241Grice EA, Segre JA. The skin microbiome. Nat Rev Microbiol. 2011 Apr;9(4):244-53. doi: 10.1038/nrmicro2537.
- Background: PubMed 29908581Musthaq S, Mazuy A, Jakus J. The microbiome in dermatology. Clin Dermatol. 2018 May-Jun;36(3):390-398. doi: 10.1016/j.clindermatol.2018.03.012. Epub 2018 Mar 10.
- Background: PubMed 27088867Perez Perez GI, Gao Z, Jourdain R, Ramirez J, Gany F, Clavaud C, Demaude J, Breton L, Blaser MJ. Body Site Is a More Determinant Factor than Human Population Diversity in the Healthy Skin Microbiome. PLoS One. 2016 Apr 18;11(4):e0151990. doi: 10.1371/journal.pone.0151990. eCollection 2016.
- Background: PubMed 30938174Sander MA, Sander MS, Isaac-Renton JL, Croxen MA. The Cutaneous Microbiome: Implications for Dermatology Practice. J Cutan Med Surg. 2019 Jul/Aug;23(4):436-441. doi: 10.1177/1203475419839939. Epub 2019 Apr 2.
- Background: PubMed 31049923Yu Y, Dunaway S, Champer J, Kim J, Alikhan A. Changing our microbiome: probiotics in dermatology. Br J Dermatol. 2020 Jan;182(1):39-46. doi: 10.1111/bjd.18088. Epub 2019 Jul 28.
- Background: PubMed 27518483Szabo K, Erdei L, Bolla BS, Tax G, Biro T, Kemeny L. Factors shaping the composition of the cutaneous microbiota. Br J Dermatol. 2017 Feb;176(2):344-351. doi: 10.1111/bjd.14967. Epub 2017 Jan 23.
- Background: PubMed 31332846Schoch JJ, Monir RL, Satcher KG, Harris J, Triplett E, Neu J. The infantile cutaneous microbiome: A review. Pediatr Dermatol. 2019 Sep;36(5):574-580. doi: 10.1111/pde.13870. Epub 2019 Jul 23.
- Background: PubMed 26922981Iebba V, Totino V, Gagliardi A, Santangelo F, Cacciotti F, Trancassini M, Mancini C, Cicerone C, Corazziari E, Pantanella F, Schippa S. Eubiosis and dysbiosis: the two sides of the microbiota. New Microbiol. 2016 Jan;39(1):1-12.
- Background: PubMed 26821151Thomas CL, Fernandez-Penas P. The microbiome and atopic eczema: More than skin deep. Australas J Dermatol. 2017 Feb;58(1):18-24. doi: 10.1111/ajd.12435. Epub 2016 Jan 28.
- Background: PubMed 18775301Holmes E, Wilson ID, Nicholson JK. Metabolic phenotyping in health and disease. Cell. 2008 Sep 5;134(5):714-7. doi: 10.1016/j.cell.2008.08.026.
- Background: PubMed 22436749Patti GJ, Yanes O, Siuzdak G. Innovation: Metabolomics: the apogee of the omics trilogy. Nat Rev Mol Cell Biol. 2012 Mar 22;13(4):263-9. doi: 10.1038/nrm3314.
- Background: PubMed 26203267Melnik BC. Linking diet to acne metabolomics, inflammation, and comedogenesis: an update. Clin Cosmet Investig Dermatol. 2015 Jul 15;8:371-88. doi: 10.2147/CCID.S69135. eCollection 2015.
- Individual participant dataSharing planned: No
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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.
Sumanas Bunyaratavej, MD principal investigator
Mahidol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4%Chlorhexidine in people with Microbial Disease and Metabolomics, run by Mahidol University at 2 sites in Thailand.
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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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?
Results are not available in the source record.
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?
Amount of skin microbiome (time frame: 2 months). The study lists 2 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 NCT04781036, which also lists 35 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 18 Mar 2024.