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OpenTrials
Completed

NCT Number: NCT02938650

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, Davis Dermatology Clinical Trials Unit

Sacramento, California, 95816, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitrosomonas eutropha

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Assessing the Role of Nitrosomonas Eutropha on Nitrolipids in the Skin

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 19, 2016
Registry last updated
Oct 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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