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Lipidome and Microbiome Profile of Acne

Primary Purpose

Acne Vulgaris

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Doxycycline

About this trial

This is an interventional health services research trial for Acne Vulgaris

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

UC Davis Dept of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

doxycycline

Control

Arm Description

Given doxycycline and assessment of gut, blood and skin

Control subjects to assess if there is baseline difference in these micro-evironments.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Change in global acne grade score

Change in the investigator global assessment of acne

Change in the lesion count of inflammatory and non-inflammatory lesions

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT02713607

First Posted

March 2, 2016

Last Updated

November 23, 2022

Sponsor

University of California, Davis

1. Study Identification

Unique Protocol Identification Number

NCT02713607

Brief Title

Lipidome and Microbiome Profile of Acne

Official Title

Lipidome and Microbiome Profile of Acne

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 2016 (undefined)

Primary Completion Date

January 2027 (Anticipated)

Study Completion Date

January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Davis

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

doxycycline

Arm Type

Experimental

Arm Description

Given doxycycline and assessment of gut, blood and skin

Arm Title

Control

Arm Type

No Intervention

Arm Description

Control subjects to assess if there is baseline difference in these micro-evironments.

Intervention Type

Drug

Intervention Name(s)

Doxycycline

Intervention Description

Given doxycycline to acne subjects

Primary Outcome Measure Information:

Title

Change in the diversity of the gut microbiome in those with and without acne.

Description

The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index and the Shannon diversity of the bacterial DNA in the gut microbiome.

Time Frame

2 years

Title

Change in the diversity of the gut microbiome before and after the treatment of doxycycline in those with acne.

Description

The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index and the Shannon diversity of the bacterial DNA in the gut microbiome.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Change in global acne grade score

Time Frame

2 years

Title

Change in the investigator global assessment of acne

Time Frame

2 years

Title

Change in the lesion count of inflammatory and non-inflammatory lesions

Time Frame

2 years

Title

Change in the diversity of the skin microbiome in those with and without acne

Description

The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index and the Shannon diversity of the bacterial DNA in the gut microbiome.

Time Frame

2 years

Title

Change in the diversity of the skin microbiome before and after treatment with doxycycline in those with acne

Description

The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index and the Shannon diversity of the bacterial DNA in the gut microbiome.

Time Frame

2 years

Title

Change in the diversity of the skin lipidome in those with and without acne

Description

The lipid profile will include quantitation of the fatty acid profiles and presence of long chain fatty acids and short chain fatty acids.

Time Frame

2 years

Title

Change in the skin lipidome before and after treatment with doxycycline in those with acne

Description

The lipid profile will include quantitation of the fatty acid profiles and presence of long chain fatty acids and short chain fatty acids.

Time Frame

2 years

Title

Change in the diversity of the blood lipidome in those with and without acne

Description

The lipid profile will include quantitation of the fatty acid profiles and presence of long chain fatty acids and short chain fatty acids.

Time Frame

2 year

Title

Change in the blood lipidome before and after treatment with doxycycline in those with

Description

The lipid profile will include quantitation of the fatty acid profiles and presence of long chain fatty acids and short chain fatty acids.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raja K Sivamani, MD MS CAT

Organizational Affiliation

UCDavis

Official's Role

Principal Investigator

Facility Information:

Facility Name

UC Davis Dept of Dermatology

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

12. IPD Sharing Statement

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Lipidome and Microbiome Profile of Acne

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