Clinical trial NCT02713607: Lipidome and Microbiome Profile of Acne
Official title: Lipidome and Microbiome Profile of Acne
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Acne Vulgaris
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

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

Primary outcomes:
measure: Change in the diversity of the gut microbiome in those with and without acne.
timeFrame: 2 years
measure: Change in the diversity of the gut microbiome before and after the treatment of doxycycline in those with acne.
timeFrame: 2 years
Secondary outcomes:
measure: Change in global acne grade score
timeFrame: 2 years
measure: Change in the investigator global assessment of acne
timeFrame: 2 years
measure: Change in the lesion count of inflammatory and non-inflammatory lesions
timeFrame: 2 years
measure: Change in the diversity of the skin microbiome in those with and without acne
timeFrame: 2 years
measure: Change in the diversity of the skin microbiome before and after treatment with doxycycline in those with acne
timeFrame: 2 years
measure: Change in the diversity of the skin lipidome in those with and without acne
timeFrame: 2 years
measure: Change in the skin lipidome before and after treatment with doxycycline in those with acne
timeFrame: 2 years
measure: Change in the diversity of the blood lipidome in those with and without acne
timeFrame: 2 year
measure: Change in the blood lipidome before and after treatment with doxycycline in those with
timeFrame: 2 years
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Dept of Dermatology
state: California
Study officials:
affiliation: UCDavis
name: Raja K Sivamani, MD MS CAT
role: PRINCIPAL_INVESTIGATOR
References: