Nitrosomonas Eutropha on Nitrolipids in the Skin

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.

Study Overview

• Status: Completed
• Conditions: Inflammation
• Intervention / Treatment: Drug: Nitrosomonas eutropha

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • University of California, Davis Dermatology Clinical Trials Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Nitrosomonas eutropha spray; Subjects will receive nitrosmonas eutropha spray that they will apply twice a day.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	one week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alteration in skin cytokines	we will assess the change in skin cytokines with the use of a non-invasive skin collection.	one week
Alteration in blood lipids	we will assess the change in blood lipids by performing a blood draw	one week
Blood pressure readings	blood pressure readings will be performed throughout the study	one week

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Actual): October 11, 2017
• Last Update Submitted That Met QC Criteria: October 9, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: inflammation; microbiome; cytokine; nitrolipid
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 916019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No