DermatitisNCT02615912
A Single-Center, Exploratory Study to Analyze the Dynamics of Skin Microflora Following Exposure to Surfactants
A study testing PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5%, Lauryl glucoside (Plantacare® 1200UP, BASF) 1.5% and Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5% in people with Dermatitis, run by Kimberly-Clark Corporation at 1 site in United States.
Trial summary
The purpose of this study is to understand the changes in skin microflora, skin barrier function, and skin biochemical constituents in response to direct contact with model surfactants used in personal care articles. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis
- What is being tested?
- PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5%, Lauryl glucoside (Plantacare® 1200UP, BASF) 1.5% and Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Feb 2016
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Subjects with Fitzpatrick Skin Types I, II or III
Who cannot join
- Subjects with visible skin disease, tattoos, skin condition, or abnormal skin color
Trial locations and contacts
1 site in 1 country.
United States1 site
Reliance Clinical Testing Service
Irving, Texas, 75062
About this study
The purpose of this study is to understand the changes in skin microflora, skin barrier function, and skin biochemical constituents in response to direct contact with model surfactants used in personal care articles. The results from this study will provide insights into the complex interaction between the skin microbiome and the epidermis after exposure to surfactants.
- Conditions
- Dermatitis
- Being tested
- PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5%, Lauryl glucoside (Plantacare® 1200UP, BASF) 1.5%, Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5%, Silwet* DA-63 (Momentive) 1.5%, Sodium lauryl sulfate (Sigma Aldrich) 1.0%
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5%Other
Lauryl glucoside (Plantacare® 1200UP, BASF) 1.5%Other
Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5%Other
Silwet* DA-63 (Momentive) 1.5%Other
Sodium lauryl sulfate (Sigma Aldrich) 1.0%Other
Water (control)Other
| Study group | Role | What they receive |
|---|---|---|
| Surfactant Exposure | Other | PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5% Lauryl glucoside (Plantacare® 1200UP, BASF) 1.5% Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5% Silwet* DA-63 (Momentive) 1.5% Sodium lauryl sulfate (Sigma Aldrich) 1.0% Water Receives: Other: PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5%; Other: Lauryl glucoside (Plantacare® 1200UP, BASF) 1.5%; Other: Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5%; Other: Silwet* DA-63 (Momentive) 1.5%; Other: Sodium lauryl sulfate (Sigma Aldrich) 1.0%; Other: Water (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of microbes present on skin after exposure to various surfactants
Microbes will be identified by metagenomic sequencing
Measured: 4 days
Amount of microbes present on skin after exposure to various surfactants
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DermatitisStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kimberly-Clark Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barry Reece, MBA, Principal investigator, RCTS, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615912
- Sponsor's protocol ID
- 500-15-0004
- Status last verified
- Sep 2016
- First submitted
- 30 Oct 2015
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Loffler H, Pirker C, Aramaki J, Frosch PJ, Happle R, Effendy I. Evaluation of skin susceptibility to irritancy by routine patch testing with sodium lauryl sulfate. Eur J Dermatol. 2001 Sep-Oct;11(5):416-9.
PubMed 11525947Hoffman DR, Kroll LM, Basehoar A, Reece B, Cunningham CT, Koenig DW. Immediate and extended effects of sodium lauryl sulphate exposure on stratum corneum natural moisturizing factor. Int J Cosmet Sci. 2014 Feb;36(1):93-101. doi: 10.1111/ics.12101. Epub 2013 Nov 20.
PubMed 24152302Torma H, Lindberg M, Berne B. Skin barrier disruption by sodium lauryl sulfate-exposure alters the expressions of involucrin, transglutaminase 1, profilaggrin, and kallikreins during the repair phase in human skin in vivo. J Invest Dermatol. 2008 May;128(5):1212-9. doi: 10.1038/sj.jid.5701170. Epub 2007 Nov 15.
PubMed 18007579Wolcott RD, Gontcharova V, Sun Y, Dowd SE. Evaluation of the bacterial diversity among and within individual venous leg ulcers using bacterial tag-encoded FLX and titanium amplicon pyrosequencing and metagenomic approaches. BMC Microbiol. 2009 Oct 27;9:226. doi: 10.1186/1471-2180-9-226.
PubMed 19860898Dowd SE, Callaway TR, Wolcott RD, Sun Y, McKeehan T, Hagevoort RG, Edrington TS. Evaluation of the bacterial diversity in the feces of cattle using 16S rDNA bacterial tag-encoded FLX amplicon pyrosequencing (bTEFAP). BMC Microbiol. 2008 Jul 24;8:125. doi: 10.1186/1471-2180-8-125.
PubMed 18652685Wolcott RD, Dowd SE. A rapid molecular method for characterising bacterial bioburden in chronic wounds. J Wound Care. 2008 Dec;17(12):513-6. doi: 10.12968/jowc.2008.17.12.31769.
PubMed 19052515
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Exploratory Study to Analyze the Dynamics of Skin Microflora Following Exposure to Surfactants
- ClinicalTrials.gov ID
- NCT02615912
- Acronym / sponsor ID
- 500-15-0004
- Conditions
- Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kimberly-Clark CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 26 Nov 2015 (estimated)
- 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 purpose of this study is to understand the changes in skin microflora, skin barrier function, and skin biochemical constituents in response to direct contact with model surfactants used in personal care articles. The results from this study will provide insights into the complex interaction between the skin microbiome and the epidermis after exposure to surfactants.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surfactant Exposure | Other | Other: PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5%, Other: Lauryl glucoside (Plantacare® 1200UP, BASF) 1.5%, Other: Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5%, Other: Silwet* DA-63 (Momentive) 1.5%, Other: Sodium lauryl sulfate (Sigma Aldrich) 1.0%, Other: Water (control)PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5% Lauryl glucoside (Plantacare® 1200UP, BASF) 1.5% Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5% Silwet* DA-63 (Momentive) 1.5% Sodium lauryl sulfate (Sigma Aldrich) 1.0% Water |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy Subjects with Fitzpatrick Skin Types I, II or III
Key exclusion criteria (1 listed)
- Subjects with visible skin disease, tattoos, skin condition, or abnormal skin color
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 |
|---|---|---|
| PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5% | Other | Surfactant Exposure |
| Lauryl glucoside (Plantacare® 1200UP, BASF) 1.5% | Other | Surfactant Exposure |
| Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5% | Other | Surfactant Exposure |
| Silwet* DA-63 (Momentive) 1.5% | Other | Surfactant Exposure |
| Sodium lauryl sulfate (Sigma Aldrich) 1.0% | Other | Surfactant Exposure |
| Water (control) | Other | Surfactant Exposure |
Primary outcome
Type of microbes present on skin after exposure to various surfactants
Time frame: 4 days
Microbes will be identified by metagenomic sequencing
Amount of microbes present on skin after exposure to various surfactants
Time frame: 4 days
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 Sep 2016.
- Background: PubMed 11525947Loffler H, Pirker C, Aramaki J, Frosch PJ, Happle R, Effendy I. Evaluation of skin susceptibility to irritancy by routine patch testing with sodium lauryl sulfate. Eur J Dermatol. 2001 Sep-Oct;11(5):416-9.
- Background: PubMed 24152302Hoffman DR, Kroll LM, Basehoar A, Reece B, Cunningham CT, Koenig DW. Immediate and extended effects of sodium lauryl sulphate exposure on stratum corneum natural moisturizing factor. Int J Cosmet Sci. 2014 Feb;36(1):93-101. doi: 10.1111/ics.12101. Epub 2013 Nov 20.
- Background: PubMed 18007579Torma H, Lindberg M, Berne B. Skin barrier disruption by sodium lauryl sulfate-exposure alters the expressions of involucrin, transglutaminase 1, profilaggrin, and kallikreins during the repair phase in human skin in vivo. J Invest Dermatol. 2008 May;128(5):1212-9. doi: 10.1038/sj.jid.5701170. Epub 2007 Nov 15.
- Background: PubMed 19860898Wolcott RD, Gontcharova V, Sun Y, Dowd SE. Evaluation of the bacterial diversity among and within individual venous leg ulcers using bacterial tag-encoded FLX and titanium amplicon pyrosequencing and metagenomic approaches. BMC Microbiol. 2009 Oct 27;9:226. doi: 10.1186/1471-2180-9-226.
- Background: PubMed 18652685Dowd SE, Callaway TR, Wolcott RD, Sun Y, McKeehan T, Hagevoort RG, Edrington TS. Evaluation of the bacterial diversity in the feces of cattle using 16S rDNA bacterial tag-encoded FLX amplicon pyrosequencing (bTEFAP). BMC Microbiol. 2008 Jul 24;8:125. doi: 10.1186/1471-2180-8-125.
- Background: PubMed 19052515Wolcott RD, Dowd SE. A rapid molecular method for characterising bacterial bioburden in chronic wounds. J Wound Care. 2008 Dec;17(12):513-6. doi: 10.12968/jowc.2008.17.12.31769.
- Individual participant dataSharing planned: Undecided
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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.
Barry Reece, MBA principal investigator
RCTS, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5%, Lauryl glucoside (Plantacare® 1200UP, BASF) 1.5% and Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5% in people with Dermatitis, run by Kimberly-Clark Corporation at 1 site in United States.
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 1 inclusion and 1 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 Sep 2016. 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 United States. 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?
Type of microbes present on skin after exposure to various surfactants (time frame: 4 days). 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 NCT02615912, which also lists 6 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 28 Sep 2016.