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Nitrosomonas Eutropha on Nitrolipids in the Skin

Primary Purpose

Inflammation

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nitrosomonas eutropha
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation focused on measuring nitrolipid, microbiome, inflammation, cytokine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, Davis Dermatology Clinical Trials Unit

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Nitrosomonas eutropha spray

Arm Description

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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

Full Information

First Posted
October 17, 2016
Last Updated
October 9, 2017
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT02938650
Brief Title
Nitrosomonas Eutropha on Nitrolipids in the Skin
Official Title
Assessing the Role of Nitrosomonas Eutropha on Nitrolipids in the Skin
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
nitrolipid, microbiome, inflammation, cytokine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nitrosomonas eutropha spray
Arm Type
Other
Arm Description
Subjects will receive nitrosmonas eutropha spray that they will apply twice a day.
Intervention Type
Drug
Intervention Name(s)
Nitrosomonas eutropha
Intervention Description
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.
Primary Outcome Measure Information:
Title
Alteration in microbiome diversity and species
Description
We will assess the alteration in the skin microbiome over a one week period by assessing the Shannon Diversity Index
Time Frame
one week
Title
Alteration in nitrolipids in the skin
Description
we will assess the change in nitrolipid profile of sebum collections from the skin after application of the nitrosomonas spray.
Time Frame
one week
Secondary Outcome Measure Information:
Title
Alteration in skin cytokines
Description
we will assess the change in skin cytokines with the use of a non-invasive skin collection.
Time Frame
one week
Title
Alteration in blood lipids
Description
we will assess the change in blood lipids by performing a blood draw
Time Frame
one week
Title
Blood pressure readings
Description
blood pressure readings will be performed throughout the study
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja K Sivamani, MD
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis Dermatology Clinical Trials Unit
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Nitrosomonas Eutropha on Nitrolipids in the Skin

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