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Nitrosomonas Eutropha on Nitrolipids in the Skin

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ClinicalTrials.gov Identifier: NCT02938650
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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

Condition or disease Intervention/treatment Phase
Inflammation Drug: Nitrosomonas eutropha Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Assessing the Role of Nitrosomonas Eutropha on Nitrolipids in the Skin
Study Start Date : October 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Alteration in skin cytokines [ Time Frame: one week ]
    we will assess the change in skin cytokines with the use of a non-invasive skin collection.

  2. Alteration in blood lipids [ Time Frame: one week ]
    we will assess the change in blood lipids by performing a blood draw

  3. Blood pressure readings [ Time Frame: one week ]
    blood pressure readings will be performed throughout the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938650


Locations
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United States, California
University of California, Davis Dermatology Clinical Trials Unit
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Raja K Sivamani, MD UC Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02938650     History of Changes
Other Study ID Numbers: 916019
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of California, Davis:
nitrolipid
microbiome
inflammation
cytokine

Additional relevant MeSH terms:
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Inflammation
Pathologic Processes