Nitrosomonas Eutropha on Nitrolipids in the Skin

Inflammation Clinical Trial

Official title:

Assessing the Role of Nitrosomonas Eutropha on Nitrolipids in the Skin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938650
• Other study ID #: 916019
• Status: Completed
• Phase: Phase 1
• First received: October 17, 2016
• Last updated: October 9, 2017
• Start date: October 2016
• Est. completion date: May 2017

Study information

• Verified date: October 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, Davis Dermatology Clinical Trials Unit	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Alteration in skin cytokines	we will assess the change in skin cytokines with the use of a non-invasive skin collection.	one week
Secondary	Alteration in blood lipids	we will assess the change in blood lipids by performing a blood draw	one week
Secondary	Blood pressure readings	blood pressure readings will be performed throughout the study	one week