Nitrosomonas Eutropha on Nitrolipids in the Skin
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02938650|
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : October 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Inflammation||Drug: Nitrosomonas eutropha||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Official Title:||Assessing the Role of Nitrosomonas Eutropha on Nitrolipids in the Skin|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||May 2017|
Nitrosomonas eutropha spray
Subjects will receive nitrosmonas eutropha spray that they will apply twice a day.
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.
- 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
- 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.
- 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.
- Alteration in blood lipids [ Time Frame: one week ]we will assess the change in blood lipids by performing a blood draw
- Blood pressure readings [ Time Frame: one week ]blood pressure readings will be performed throughout the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938650
|United States, California|
|University of California, Davis Dermatology Clinical Trials Unit|
|Sacramento, California, United States, 95816|
|Principal Investigator:||Raja K Sivamani, MD||UC Davis|