Nitrosomonas Eutropha on Nitrolipids in the Skin

NCT02938650 | Completed Phase 1

• 1 other identifier: 916019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inflammation

Keywords

nitrolipid; microbiome; inflammation; cytokine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Alteration in skin cytokines

  one week

• Alteration in blood lipids

  one week

• Blood pressure readings

  one week

Study Arms (1)

Nitrosomonas eutropha spray

OTHER

Subjects will receive nitrosmonas eutropha spray that they will apply twice a day.

Drug: Nitrosomonas eutropha

Interventions

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.

Nitrosomonas eutropha spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis Dermatology Clinical Trials Unit

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Raja K Sivamani, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 19, 2016
• Study Start: October 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: October 11, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)