MedDataX Logo

Nitrosomonas Eutropha on Nitrolipids in the Skin

NCT ID: NCT02938650

Last Updated: 2017-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

We are looking to see how the addition of nitrosomonas alters the presence of nitrolipids and inflammatory cytokines on the skin.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

nitrolipid microbiome inflammation cytokine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nitrosomonas eutropha spray

Subjects will receive nitrosmonas eutropha spray that they will apply twice a day.

Group Type OTHER

Nitrosomonas eutropha

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nitrosomonas eutropha

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Those aged 18 and over
* Healthy Subjects with clear skin

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Raja K Sivamani, MD

Role: PRINCIPAL_INVESTIGATOR

UC Davis

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, Davis Dermatology Clinical Trials Unit

Sacramento, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

916019

Identifier Type: -

Identifier Source: org_study_id