Nitrosomonas Eutropha on Nitrolipids in the Skin

Phase 1

Completed

• Conditions: Inflammation
• Interventions: Drug: Nitrosomonas eutropha

• Registration Number: NCT02938650
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-19
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-09
• Last Update Posted: 2017-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nitrosomonas eutropha spray	Nitrosomonas eutropha	Subjects will receive nitrosmonas eutropha spray that they will apply twice a day.

Primary Outcome Measures

Name	Time	Method
Alteration in microbiome diversity and species	one week	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	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

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

Trial Locations

Locations (1)

University of California, Davis Dermatology Clinical Trials Unit; 🇺🇸 Sacramento, California, United States