Skin HealthPhase 4NCT03348917
The Effect of Skin Cleansers on the Skin Surface Microbiome
A Phase 4 study testing 7.5% Povidone-Iodine [PVP-I], 4% chlorhexidine skin cleanser and Plain non antibacterial soap in people with Skin Health, run by Mundipharma Manufacturing Pte Ltd. at 1 site in Singapore.
Trial summary
This study determines the effects of a single application of different antiseptic skin cleansers on the composition of the skin surface microbiome using next-generation sequencing (NGS) techniques. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Health
- What is being tested?
- 7.5% Povidone-Iodine [PVP-I], 4% chlorhexidine skin cleanser and Plain non antibacterial soap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSingapore
- Study dates
- 28 Dec 2017to 26 Jan 2018
- Phase
- Phase 4
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects between age 21 to 65 years
- Must wear short sleeved shirts/blouses during each visit
- Non-smoker
- Good general and mental health with, in the opinion of investigator or the qualified medical designee:
- No clinically significant and relevant abnormalities of medical history or physical examination;
- Absence of any condition that would impact the subject's safety or health or affect the subject's ability to understand and comply with the study procedures.
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- Prepared to use the provided wash products that do not contain any antimicrobials (non antibacterial shampoo [Pantene® Pro-V], non antibacterial body wash [Dove®body wash] and non antibacterial hand wash [Guardian gel hand wash]) after providing consent and during the whole study
- Healthy and intact skin in the test area (e.g., no skin allergy, visible bleeding, skin inflammation, skin ulcer or skin lesion, no need for cutaneous treatment)
- Must have given written informed consent
- Women of child-bearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.
Who cannot join
- Women who are pregnant or have a positive urine pregnancy test or intending to become pregnant during the overall study period
- Women who are breast-feeding
- Allergy or contraindication to any test product substance (active or excipients)
- Any visible signs of skin dermatitis on the hands, e.g., eczema
- Use of anti-dandruff shampoo or any other shampoo/hand/body wash products apart from those provided, within 2 days prior to Visit 2 (Day 0) and also during the whole study
- Systemic or topical or oral antibiotic or antifungal in the past 2 months before Screening and during the study
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- Medication use (e.g., lithium therapy, immunosuppressive medication, systemic or inhaled glucocorticoids) in the past 2 months before Screening and during the study
- Recent history (within the last 1 year) of alcohol or other substance abuse
- Known hyperthyroidism or other ongoing thyroid diseases
- Minor ailments such as like cough, cold, upper respiratory tract infection(s) within 2 weeks and during the study
- Any known serious ongoing disease
- Unwillingness or inability to comply with the requirements of the protocol
- Participation in any other drug, biologic, device, or clinical study or treatment with any investigational drug or approved therapy for investigational use within 30 days (or 5 half-lives, whichever is longer) before Screening
- An employee of the sponsor or study site or their immediate family member
- Subject who has been treated with cancer within the last 1 year.
Trial locations and contacts
1 site in 1 country.
About this study
This study determines the effects of a single application of different antiseptic skin cleansers on the composition of the skin surface microbiome using next-generation sequencing (NGS) techniques. Twelve healthy volunteers will receive all three test products in a randomized order to compare the effects of each skin cleanser.
Read the detailed description
Disinfectants and oral antiseptics including PVP-I are known to kill microorganisms to a variable extent, at a variable range of time points. Microorganisms may be protected from disinfectants by production of thick masses of cells and extracellular materials, or biofilms. Moreover, antiseptics should not lead to dysbiosis after use. Dysbiosis is a negative change in the microbiome of a particular skin or mucosal region. The Human Microbiome project showed, that every area has a specific microbiota in which the human host lives with an abundance of commensal, synergistic, and potentially pathogenic microorganisms. Antiseptics with efficacy gaps and resistance may induce such dysbiosis, especially after prolonged use. It is envisaged that twelve healthy volunteers will complete the study. Each healthy volunteer will apply the test product according to a developed protocol, between established wash out periods.
The ability of the test product (Commercially available - Betadine® 7.5% skin cleanser (PVP-I 7.5%)) compared to the reference products (commercially available 4% chlorhexidine skin cleanser - Unity antiseptic hand wash (no alcohol) and Plain non antibacterial soap - Guardian gel hand wash (not medicated)) to reduce resident and transient microflora will be assessed. The hand wash products will also be assessed for their ability to maintain and/or restore balanced microflora.
- Conditions
- Skin Health
- Being tested
- 7.5% Povidone-Iodine [PVP-I], 4% chlorhexidine skin cleanser, Plain non antibacterial soap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7.5% Povidone-Iodine [PVP-I]Drug
Betadine® 7.5% skin cleanser (PVP-I 7.5%)
4% chlorhexidine skin cleanserDrug
Unity antiseptic hand wash (no alcohol)
Plain non antibacterial soapDrug
Guardian gel hand wash (not medicated),
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence Group 1 | Active comparator | Treatment Sequence Group 1 = A -> B -> C
Treatment A = Betadine® 7.5% skin cleanser (PVP-I 7.5%)
Treatment B = 4% chlorhexidine skin cleanser - Unity antiseptic hand wash (no alcohol)
Treatment C = Plain non antibacterial soap - Guardian gel hand wash (not medicated) Receives: Drug: 7.5% Povidone-Iodine [PVP-I]; Drug: 4% chlorhexidine skin cleanser; Drug: Plain non antibacterial soap |
| Treatment sequence Group 2 | Active comparator | Treatment Sequence Group 2 = B -> C -> A
Treatment B = 4% chlorhexidine skin cleanser - Unity antiseptic hand wash (no alcohol)
Treatment C = Plain non antibacterial soap - Guardian gel hand wash (not medicated)
Treatment A = Betadine® 7.5% skin cleanser (PVP-I 7.5%) Receives: Drug: 7.5% Povidone-Iodine [PVP-I]; Drug: 4% chlorhexidine skin cleanser; Drug: Plain non antibacterial soap |
| Treatment sequence Group 3 | Active comparator | Treatment Sequence Group 3 = C -> A ->B
Treatment C = Plain non antibacterial soap - Guardian gel hand wash (not medicated)
Treatment A = Betadine® 7.5% skin cleanser (PVP-I 7.5%)
Treatment B = 4% chlorhexidine skin cleanser - Unity antiseptic hand wash (no alcohol) Receives: Drug: 7.5% Povidone-Iodine [PVP-I]; Drug: 4% chlorhexidine skin cleanser; Drug: Plain non antibacterial soap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition of skin microbiome - reduction of microflora amount
The change in amount of skin microflora species composition from baseline after the usage of a single application of different skin cleansers using next generation sequencing (NGS) and real-time PCR techniques at 3 mins and 240 mins.
Measured: [Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]
Composition of skin microbiome - maintenance of healthy microflora amount
The change in amount of healthy skin microflora species composition from baseline after the usage of a single application of different skin cleansers using next generation sequencing (NGS) and real-time PCR techniques at 3 mins and 240 mins.
Measured: [Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]
Composition of skin microbiome - reduction of microflora variety
The change in variety of skin microflora species composition from baseline after the usage of a single application of different skin cleansers using next generation sequencing (NGS) and real-time PCR techniques at 3 mins and 240 mins.
Measured: [Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]
Composition of skin microbiome - maintenance of healthy microflora variety
The change in variety of healthy skin microflora species composition from baseline after the usage of a single application of different skin cleansers using next generation sequencing (NGS) and real-time PCR techniques at 3 mins and 240 mins.
Measured: [Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start28 Dec 2017
- Primary completion26 Jan 2018
- Study completion26 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin HealthStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Twelve healthy volunteers will be randomized into three arms with three different treatment sequences with four healthy volunteers in each arm. Up to fifteen healthy volunteers may be recruited with the consideration that up to three subjects may drop out.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Manufacturing Pte Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genome Institute of Singapore
- Responsible party
- Sponsor
- Investigators
- Nisha Su Yien Subash Chandran, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348917
- Sponsor's protocol ID
- BTD16-SG-402
- Status last verified
- Feb 2018
- First submitted
- 16 Nov 2017
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Skin Cleansers on the Skin Surface Microbiome
- ClinicalTrials.gov ID
- NCT03348917
- Acronym / sponsor ID
- BTD16-SG-402
- Conditions
- Skin Health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mundipharma Manufacturing Pte Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Genome Institute of Singapore
- Study start
- 28 Dec 2017 (actual)
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 26 Jan 2018 (actual)
- First posted
- 21 Nov 2017 (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 determines the effects of a single application of different antiseptic skin cleansers on the composition of the skin surface microbiome using next-generation sequencing (NGS) techniques. Twelve healthy volunteers will receive all three test products in a randomized order to compare the effects of each skin cleanser.
Detailed description
Disinfectants and oral antiseptics including PVP-I are known to kill microorganisms to a variable extent, at a variable range of time points. Microorganisms may be protected from disinfectants by production of thick masses of cells and extracellular materials, or biofilms. Moreover, antiseptics should not lead to dysbiosis after use. Dysbiosis is a negative change in the microbiome of a particular skin or mucosal region. The Human Microbiome project showed, that every area has a specific microbiota in which the human host lives with an abundance of commensal, synergistic, and potentially pathogenic microorganisms. Antiseptics with efficacy gaps and resistance may induce such dysbiosis, especially after prolonged use. It is envisaged that twelve healthy volunteers will complete the study. Each healthy volunteer will apply the test product according to a developed protocol, between established wash out periods.
The ability of the test product (Commercially available - Betadine® 7.5% skin cleanser (PVP-I 7.5%)) compared to the reference products (commercially available 4% chlorhexidine skin cleanser - Unity antiseptic hand wash (no alcohol) and Plain non antibacterial soap - Guardian gel hand wash (not medicated)) to reduce resident and transient microflora will be assessed. The hand wash products will also be assessed for their ability to maintain and/or restore balanced microflora.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Twelve healthy volunteers will be randomized into three arms with three different treatment sequences with four healthy volunteers in each arm. Up to fifteen healthy volunteers may be recruited with the consideration that up to three subjects may drop out.
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence Group 1 | Active comparator | Drug: 7.5% Povidone-Iodine [PVP-I], Drug: 4% chlorhexidine skin cleanser, Drug: Plain non antibacterial soapTreatment Sequence Group 1 = A -> B -> C Treatment A = Betadine® 7.5% skin cleanser (PVP-I 7.5%) Treatment B = 4% chlorhexidine skin cleanser - Unity antiseptic hand wash (no alcohol) Treatment C = Plain non antibacterial soap - Guardian gel hand wash (not medicated) |
| Treatment sequence Group 2 | Active comparator | Drug: 7.5% Povidone-Iodine [PVP-I], Drug: 4% chlorhexidine skin cleanser, Drug: Plain non antibacterial soapTreatment Sequence Group 2 = B -> C -> A Treatment B = 4% chlorhexidine skin cleanser - Unity antiseptic hand wash (no alcohol) Treatment C = Plain non antibacterial soap - Guardian gel hand wash (not medicated) Treatment A = Betadine® 7.5% skin cleanser (PVP-I 7.5%) |
| Treatment sequence Group 3 | Active comparator | Drug: 7.5% Povidone-Iodine [PVP-I], Drug: 4% chlorhexidine skin cleanser, Drug: Plain non antibacterial soapTreatment Sequence Group 3 = C -> A ->B Treatment C = Plain non antibacterial soap - Guardian gel hand wash (not medicated) Treatment A = Betadine® 7.5% skin cleanser (PVP-I 7.5%) Treatment B = 4% chlorhexidine skin cleanser - Unity antiseptic hand wash (no alcohol) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female subjects between age 21 to 65 years
- Must wear short sleeved shirts/blouses during each visit
- Non-smoker
- Good general and mental health with, in the opinion of investigator or the qualified medical designee:
- Prepared to use the provided wash products that do not contain any antimicrobials (non antibacterial shampoo [Pantene® Pro-V], non antibacterial body wash [Dove®body wash] and non antibacterial hand wash [Guardian gel hand wash]) after providing consent and during the whole study
Key exclusion criteria (15 listed)
- Women who are pregnant or have a positive urine pregnancy test or intending to become pregnant during the overall study period
- Women who are breast-feeding
- Allergy or contraindication to any test product substance (active or excipients)
- Any visible signs of skin dermatitis on the hands, e.g., eczema
- Use of anti-dandruff shampoo or any other shampoo/hand/body wash products apart from those provided, within 2 days prior to Visit 2 (Day 0) and also during the whole study
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 |
|---|---|---|
| 7.5% Povidone-Iodine [PVP-I]Betadine® 7.5% skin cleanser (PVP-I 7.5%) | Drug | Treatment sequence Group 1, Treatment sequence Group 2, Treatment sequence Group 3 |
| 4% chlorhexidine skin cleanserUnity antiseptic hand wash (no alcohol) | Drug | Treatment sequence Group 1, Treatment sequence Group 2, Treatment sequence Group 3 |
| Plain non antibacterial soapGuardian gel hand wash (not medicated), | Drug | Treatment sequence Group 1, Treatment sequence Group 2, Treatment sequence Group 3 |
Primary outcome
Composition of skin microbiome - reduction of microflora amount
Time frame: [Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]
The change in amount of skin microflora species composition from baseline after the usage of a single application of different skin cleansers using next generation sequencing (NGS) and real-time PCR techniques at 3 mins and 240 mins.
Composition of skin microbiome - maintenance of healthy microflora amount
Time frame: [Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]
The change in amount of healthy skin microflora species composition from baseline after the usage of a single application of different skin cleansers using next generation sequencing (NGS) and real-time PCR techniques at 3 mins and 240 mins.
Composition of skin microbiome - reduction of microflora variety
Time frame: [Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]
The change in variety of skin microflora species composition from baseline after the usage of a single application of different skin cleansers using next generation sequencing (NGS) and real-time PCR techniques at 3 mins and 240 mins.
Composition of skin microbiome - maintenance of healthy microflora variety
Time frame: [Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]
The change in variety of healthy skin microflora species composition from baseline after the usage of a single application of different skin cleansers using next generation sequencing (NGS) and real-time PCR techniques at 3 mins and 240 mins.
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 28 Feb 2018.
- 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.
Nisha Su Yien Subash Chandran principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 7.5% Povidone-Iodine [PVP-I], 4% chlorhexidine skin cleanser and Plain non antibacterial soap in people with Skin Health, run by Mundipharma Manufacturing Pte Ltd. at 1 site in Singapore.
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 10 inclusion and 15 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 28 Feb 2018. 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 Singapore. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Composition of skin microbiome - reduction of microflora amount (time frame: [Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2018.