DysbiosisNCT04476732
Interactions Between Skincare Product Ingredients and the Skin Microbiome
A study testing Paraben-free skincare product and Paraben-containing skincare product in people with Dysbiosis, run by University of California, Davis at 1 site in United States.
Trial summary
This is a study of the influence of skincare products containing chemicals such as parabens and phthalates on the skin microbiome. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysbiosis
- What is being tested?
- Paraben-free skincare product and Paraben-containing skincare product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2020to 16 Jul 2020
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Individuals aged 15 and over
- No known medical conditions that, in the investigator's opinion, may interfere with study participation.
Who cannot join
- Individuals who have been on any medication (including antibiotics, probiotics, prebiotics) that has caused a change in current skin composition of interest based on the opinion of the investigator.
- Individuals with systemic antibiotic use within last 60 days.
- Individuals with topical antibiotic use on the test sites within last 30 days
- Individuals unwilling/unable to avoid topical antibiotics, systemic antibiotics, prebiotics, and probiotics during study.
- No other interfering skin products should be used during duration of study. (Paraben-free \& phthalate-free personal product "safe" list will be provided for other uses during study period if needed).
- Individuals unwilling or unable to undergo 1 week wash-in with paraben/phthalate-free products if needed in the opinion of the investigator.
Show all 12Show fewer
- Female volunteers who are pregnant or are actively breastfeeding or planning a pregnancy within two months. (There is no known concern for risk to fetus but pregnancy can alter the microbiome being studied)
- Female volunteers who have started a new hormonal birth control agent or switched to a hormonal birth control agent within the past 60 days
- Individuals using any interfering skin products in the opinion of the investigator within 2 weeks of enrollment into the study.
- Individuals who have participated in any other clinical studies using the same test sites (face) in the past 14 days
- Individuals with a known history of hypersensitivity to any ingredients to the cosmetic agent that is being assessed
- Individuals who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Dermatology Department
Sacramento, California, 95820
About this study
This is a study of the influence of skincare products containing chemicals such as parabens and phthalates on the skin microbiome.
Read the detailed description
Skin serves as a critical barrier between our bodies and the environment and the locus for a diverse and active microbial community. The composition and metabolic activity of the microbial community on the skin is presumably influenced by the local chemical environment, which includes natural skin lipids (e.g., squalene and sapienic acid), components of personal care products applied directly to skin, and semi-volatile organic compounds (SVOCs) that reach the skin through gas phase absorption, dust deposition, and direct contact with surfaces. Common semi-volatile ingredients in skin care products include phthalates, parabens, and UV blocking compounds (e.g., oxybenzone, octocrylene or homosalate).
The investigators have recently demonstrated a method of collecting chemicals from areas of skin with infrequent direct dermal contact using alcohol wipes to assess passive air to skin partitioning of both target and nontarget compounds (Garrido et al., in review). Low-volatility reaction products can accumulate in skin oils and act as skin irritants, with the potential of being absorbed into the bloodstream. With methods developed for chemical and microbiome sampling, the overall goal of the proposed research is to develop an understanding of the two-way interaction between organic chemicals on the skin and the composition of the skin microbiome.
- Conditions
- Dysbiosis
- Being tested
- Paraben-free skincare product, Paraben-containing skincare product
- Keywords
- microbiome, skincare, skin, paraben, phthalate
- Medical subject headings
- Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paraben-free skincare productOther
Paraben-free lotion will be applied twice a day for one week.
Paraben-containing skincare productOther
Paraben-containing lotion will be applied twice a day for one week.
| Study group | Role | What they receive |
|---|---|---|
| Paraben-free then Paraben-containing | Experimental | Paraben free facial lotion is applied twice a day for 1 week and measurements are taken. Then, paraben-containing facial lotion is applied twice a day for 1 week and measurements are taken. Receives: Other: Paraben-free skincare product; Other: Paraben-containing skincare product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in detected paraben levels
Demonstrate the ability to detect chemicals (specifically parabens) found in common ingredients in personal care products on human skin. Collection of isopropyl alcohol forehead wipe and subsequent detection and quantification of parabens by GC-QTOF-MS (gas chromatography) and LC-QTOF-MS (liquid chromatography). Comparisons between baseline, week 1, and week 2 will be made.
Measured: Baseline, 1 week, 2 weeks
Secondary outcomes (1)
Influence of skincare product ingredient (specifically parabens) on facial skin microbiome
Document changes in microbial community composition following application of skin care ingredients of controversial concern (parabens) in comparison with changes following application of products not containing these ingredients. This is assessed by facial swab collections, DNA extraction, and determination of a list of specific bacterial species present at each time point. Comparisons between baseline, week 1, and week 2 will be made.
Measured: Baseline, 1 week, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start11 Feb 2020
- Primary completion16 Jul 2020
- Study completion16 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysbiosisStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raja K Sivamani, MD, Principal investigator, UC Davis Dermatology Clinical Trials Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476732
- Sponsor's protocol ID
- 1529276
- Status last verified
- Jul 2020
- First submitted
- 15 May 2020
- Last updated
- 3 Aug 2020
- 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 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactions Between Skincare Product Ingredients and the Skin Microbiome
- ClinicalTrials.gov ID
- NCT04476732
- Acronym / sponsor ID
- 1529276
- Conditions
- Dysbiosis
- Keywords
- microbiome, skincare, skin, paraben, phthalate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 16 Jul 2020 (actual)
- Study completion
- 16 Jul 2020 (actual)
- First posted
- 20 Jul 2020 (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 is a study of the influence of skincare products containing chemicals such as parabens and phthalates on the skin microbiome.
Detailed description
Skin serves as a critical barrier between our bodies and the environment and the locus for a diverse and active microbial community. The composition and metabolic activity of the microbial community on the skin is presumably influenced by the local chemical environment, which includes natural skin lipids (e.g., squalene and sapienic acid), components of personal care products applied directly to skin, and semi-volatile organic compounds (SVOCs) that reach the skin through gas phase absorption, dust deposition, and direct contact with surfaces. Common semi-volatile ingredients in skin care products include phthalates, parabens, and UV blocking compounds (e.g., oxybenzone, octocrylene or homosalate).
The investigators have recently demonstrated a method of collecting chemicals from areas of skin with infrequent direct dermal contact using alcohol wipes to assess passive air to skin partitioning of both target and nontarget compounds (Garrido et al., in review). Low-volatility reaction products can accumulate in skin oils and act as skin irritants, with the potential of being absorbed into the bloodstream. With methods developed for chemical and microbiome sampling, the overall goal of the proposed research is to develop an understanding of the two-way interaction between organic chemicals on the skin and the composition of the skin microbiome.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paraben-free then Paraben-containing | Experimental | Other: Paraben-free skincare product, Other: Paraben-containing skincare productParaben free facial lotion is applied twice a day for 1 week and measurements are taken. Then, paraben-containing facial lotion is applied twice a day for 1 week and measurements are taken. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals aged 15 and over
- No known medical conditions that, in the investigator's opinion, may interfere with study participation.
Key exclusion criteria (12 listed)
- Individuals who have been on any medication (including antibiotics, probiotics, prebiotics) that has caused a change in current skin composition of interest based on the opinion of the investigator.
- Individuals with systemic antibiotic use within last 60 days.
- Individuals with topical antibiotic use on the test sites within last 30 days
- Individuals unwilling/unable to avoid topical antibiotics, systemic antibiotics, prebiotics, and probiotics during study.
- No other interfering skin products should be used during duration of study. (Paraben-free \& phthalate-free personal product "safe" list will be provided for other uses during study period if needed).
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 |
|---|---|---|
| Paraben-free skincare productParaben-free lotion will be applied twice a day for one week. | Other | Paraben-free then Paraben-containing |
| Paraben-containing skincare productParaben-containing lotion will be applied twice a day for one week. | Other | Paraben-free then Paraben-containing |
Primary outcome
Change in detected paraben levels
Time frame: Baseline, 1 week, 2 weeks
Demonstrate the ability to detect chemicals (specifically parabens) found in common ingredients in personal care products on human skin. Collection of isopropyl alcohol forehead wipe and subsequent detection and quantification of parabens by GC-QTOF-MS (gas chromatography) and LC-QTOF-MS (liquid chromatography). Comparisons between baseline, week 1, and week 2 will be made.
1 secondary outcome
Influence of skincare product ingredient (specifically parabens) on facial skin microbiome
Time frame: Baseline, 1 week, 2 weeks
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 3 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Dysbiosis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Enrolling by invitationPhase 2
Herbal Supplement (Biocidin REMOVE) for Bacterial Overgrowth in Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
RecruitingObservational study
Effects Of Periodontal Therapy In Patients With Inflammatory Bowel Disease
Periodontal Diseases, IBD
Recruiting
Effect of a Probiotic or Postbiotic on Gut Microbiome During Antibiotic Treatment
Microbiome
RecruitingObservational study
Metabolic and Functional Study of γδ T Cells in Critically Ill Patients
Sepsis, Critical Illness
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.
Raja K Sivamani, MD principal investigator
UC Davis Dermatology Clinical Trials Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paraben-free skincare product and Paraben-containing skincare product in people with Dysbiosis, run by University of California, Davis 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 2 inclusion and 12 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 3 Aug 2020. 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?
Change in detected paraben levels (time frame: Baseline, 1 week, 2 weeks). 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 3 Aug 2020.