Nitrosomonas Eutropha on Nitrolipids in the Skin

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

Detailed Description
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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.

Official Title
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Assessing the Role of Nitrosomonas Eutropha on Nitrolipids in the Skin

Conditions
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Inflammation

Intervention / Treatment
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* Drug: Nitrosomonas eutropha


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Nitrosomonas eutropha spray<br>Subjects will receive nitrosmonas eutropha spray that they will apply twice a day. | Drug: Nitrosomonas eutropha<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nitrolipid, microbiome, inflammation, cytokine