Lipidome and Microbiome Profile of Acne

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Doxycycline

Detailed Description

We will look at acne subjects, and controls.

We will look at four things

1. skin lipidome
2. skin microbiome
3. gut microbiome
4. blood lipidome

Investigators will assess this in acne participants before and after doxycycline and compare them to controls.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • UC Davis Dept of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: doxycycline; Given doxycycline and assessment of gut, blood and skin	Drug: Doxycycline; Given doxycycline to acne subjects
No Intervention: Control; 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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Raja K Sivamani, MD MS CAT, UCDavis

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: March 14, 2016
• First Posted (Estimated): March 21, 2016

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: 867744