InflammationPhase 1NCT02938650
Nitrosomonas Eutropha on Nitrolipids in the Skin
A Phase 1 study testing Nitrosomonas eutropha in people with Inflammation, run by University of California, Davis at 1 site in United States.
Trial summary
We are looking to see how the addition of nitrosomonas alters the presence of nitrolipids and inflammatory cytokines on the skin. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Nitrosomonas eutropha
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to May 2017
- Phase
- Phase 1
- 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
Who may be able to join
- Those aged 18 and over
- Healthy Subjects with clear skin
Who cannot join
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Those with acne, eczema, seborrheic dermatitis, rosacea or polycystic ovarian syndrome
- Those who have started new oral medication in the last four weeks
Show all 16Show fewer
- Those who have used systemic antibiotics in the last month
- Those who have used isotretinoin in the last 6 weeks
- Those who have used topical antibiotics or retinoid in the last two weeks.
- Those who have autoimmune or metabolic diseases
- Those who have changed brands of oral contraceptive within the last four weeks
- Those who have chronic medical disorders
- Those whose with active skin infections
- Concomitant use of nitrates
- Concomitant use of anti-hypertensive agents
- Those with syncopal episodes
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Dermatology Clinical Trials Unit
Sacramento, California, 95816
About this study
Official title: Assessing the Role of Nitrosomonas Eutropha on Nitrolipids in the Skin
We are looking to see how the addition of nitrosomonas alters the presence of nitrolipids and inflammatory cytokines on the skin.
Read the detailed description
We are looking to see how the nitrosomonas alters nitrolipids in the skin and the inflammatory cytokines of the skin.
We will be using healthy subjects over the course of 2 weeks.
Subjects will be using a neutral cleanser for one week prior to the study, skin microbiome,facial photography, lipid and cytokine measurements will be taken at baseline. Subjects will then start using nitrosomonas spray twice daily for one week.
There is a portion of the study where the subjects will have skin microbiome, facial photography, lipid measurements, blood pressure measurements and a bloow draw before and after using the nitrosomonas spray for one week.
- Conditions
- Inflammation
- Being tested
- Nitrosomonas eutropha
- Keywords
- nitrolipid, microbiome, inflammation, cytokine
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrosomonas eutrophaDrug
Subjects will get nitrosomonas eutropha to apply for one week. There is only one arm to this study. Subjects will apply the medication twice a day for one week.
| Study group | Role | What they receive |
|---|---|---|
| Nitrosomonas eutropha spray | Other | Subjects will receive nitrosmonas eutropha spray that they will apply twice a day. Receives: Drug: Nitrosomonas eutropha |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alteration in microbiome diversity and species
We will assess the alteration in the skin microbiome over a one week period by assessing the Shannon Diversity Index
Measured: one week
Alteration in nitrolipids in the skin
we will assess the change in nitrolipid profile of sebum collections from the skin after application of the nitrosomonas spray.
Measured: one week
Secondary outcomes (3)
Alteration in skin cytokines
we will assess the change in skin cytokines with the use of a non-invasive skin collection.
Measured: one week
Alteration in blood lipids
we will assess the change in blood lipids by performing a blood draw
Measured: one week
Blood pressure readings
blood pressure readings will be performed throughout the study
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 15 healthy controls will participate in the study Another set of healthy controls (n=20) will be recruited so that they participate in blood draws.
- Masking
- None (open label)
- Enrolment
- 30 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938650
- Sponsor's protocol ID
- 916019
- Status last verified
- Oct 2017
- First submitted
- 17 Oct 2016
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Role of Nitrosomonas Eutropha on Nitrolipids in the Skin
- ClinicalTrials.gov ID
- NCT02938650
- Acronym / sponsor ID
- 916019
- Conditions
- Inflammation
- Keywords
- nitrolipid, microbiome, inflammation, cytokine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 19 Oct 2016 (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.
We are looking to see how the addition of nitrosomonas alters the presence of nitrolipids and inflammatory cytokines on the skin.
Detailed description
We are looking to see how the nitrosomonas alters nitrolipids in the skin and the inflammatory cytokines of the skin.
We will be using healthy subjects over the course of 2 weeks.
Subjects will be using a neutral cleanser for one week prior to the study, skin microbiome,facial photography, lipid and cytokine measurements will be taken at baseline. Subjects will then start using nitrosomonas spray twice daily for one week.
There is a portion of the study where the subjects will have skin microbiome, facial photography, lipid measurements, blood pressure measurements and a bloow draw before and after using the nitrosomonas spray for one week.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 15 healthy controls will participate in the study Another set of healthy controls (n=20) will be recruited so that they participate in blood draws.
| Arm | Type | Receives |
|---|---|---|
| Nitrosomonas eutropha spray | Other | Drug: Nitrosomonas eutrophaSubjects will receive nitrosmonas eutropha spray that they will apply twice a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Those aged 18 and over
- Healthy Subjects with clear skin
Key exclusion criteria (16 listed)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Those with acne, eczema, seborrheic dermatitis, rosacea or polycystic ovarian syndrome
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 |
|---|---|---|
| Nitrosomonas eutrophaSubjects will get nitrosomonas eutropha to apply for one week. There is only one arm to this study. Subjects will apply the medication twice a day for one week. | Drug | Nitrosomonas eutropha spray |
Primary outcome
Alteration in microbiome diversity and species
Time frame: one week
We will assess the alteration in the skin microbiome over a one week period by assessing the Shannon Diversity Index
Alteration in nitrolipids in the skin
Time frame: one week
we will assess the change in nitrolipid profile of sebum collections from the skin after application of the nitrosomonas spray.
3 secondary outcomes
Alteration in skin cytokines
Time frame: one week
Alteration in blood lipids
Time frame: one week
Blood pressure readings
Time frame: one week
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 11 Oct 2017.
- 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.
Raja K Sivamani, MD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nitrosomonas eutropha in people with Inflammation, 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 16 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 11 Oct 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Alteration in microbiome diversity and species (time frame: one week). 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?
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 11 Oct 2017.