Lipidome and Microbiome Profile of Acne

Study Overview
=================
Brief Summary
-----------------
Lipidome and microbiome analysis in subjects with acne on doxycycline. Investigators will look at the skin lipidome, blood lipidome, gut micro biome and skin micro biome. Investigators will look at the changes between acne subjects and control participants, but also the changes that occur after the use of antibiotics and how this is altered.

Detailed Description
-----------------
We will look at acne subjects, and controls. We will look at four things skin lipidome skin microbiome gut microbiome blood lipidome Investigators will assess this in acne participants before and after doxycycline and compare them to controls.

Official Title
-----------------
Lipidome and Microbiome Profile of Acne

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: Doxycycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 15 and older Subjects/parents/legal guardian is able to read and comprehend study procedure and consent forms. Have already been prescribed Doxycycline by their physician for acne or to be eligible to be prescribed Doxycycline for acne Have acne that is diagnosed by a board certified dermatologist. Exclusion Criteria: Those who have received systemic antibiotics within four weeks of starting the study. Those who have received systemic isotretinoin within six weeks of starting the study. Those with seborrheic dermatitis, rosacea, or polycystic ovary syndrome Those who are pregnant, prisoners or cognitively impaired. Those subjects who are currently using proton pump inhibits (as studies have shown this may impact the gut microbiome) (4) Those who have a BMI greater than >30 kg/m2, as studies have shown a reduction in the variability of intestinal microbes within this population (5). Those who have initiated or changed brand of oral contraceptive pill within 4 weeks of starting the study. Those who have autoimmune disorders as this group has been shown to have an altered microbiome (6) Those who have diabetes (6), immunodeficiencies (7), inflammatory bowel disease (6), hypercholesterolemia, as these groups have been shown to have altered gut microbiomes Those who have taken oral probiotic supplements (8) within 4 weeks of starting the study Given the nature of the instructions that need to be adhered to for accurate collection of samples and this data, non-English speaking individuals will be excluded from this pilot study. Allergies to the tetracycline group of antibiotics Those who do not fit the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: doxycycline<br>Given doxycycline and assessment of gut, blood and skin | Drug: Doxycycline<br>* Given doxycycline to acne subjects<br>|
| No Intervention: Control<br>Control subjects to assess if there is baseline difference in these micro-evironments. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the diversity of the gut microbiome in those with and without acne. | The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index and the Shannon diversity of the bacterial DNA in the gut microbiome. | 2 years | 
| Change in the diversity of the gut microbiome before and after the treatment of doxycycline in those with acne. | The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index and the Shannon diversity of the bacterial DNA in the gut microbiome. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in global acne grade score |  | 2 years | 
| Change in the investigator global assessment of acne |  | 2 years | 
| Change in the lesion count of inflammatory and non-inflammatory lesions |  | 2 years | 
| Change in the diversity of the skin microbiome in those with and without acne | The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index and the Shannon diversity of the bacterial DNA in the gut microbiome. | 2 years | 
| Change in the diversity of the skin microbiome before and after treatment with doxycycline in those with acne | The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index and the Shannon diversity of the bacterial DNA in the gut microbiome. | 2 years | 
| Change in the diversity of the skin lipidome in those with and without acne | The lipid profile will include quantitation of the fatty acid profiles and presence of long chain fatty acids and short chain fatty acids. | 2 years | 
| Change in the skin lipidome before and after treatment with doxycycline in those with acne | The lipid profile will include quantitation of the fatty acid profiles and presence of long chain fatty acids and short chain fatty acids. | 2 years | 
| Change in the diversity of the blood lipidome in those with and without acne | The lipid profile will include quantitation of the fatty acid profiles and presence of long chain fatty acids and short chain fatty acids. | 2 year | 
| Change in the blood lipidome before and after treatment with doxycycline in those with | The lipid profile will include quantitation of the fatty acid profiles and presence of long chain fatty acids and short chain fatty acids. | 2 years |