Lipidome and Microbiome Profile of Acne

NCT ID: NCT02713607

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2027-01-31

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

doxycycline

Given doxycycline and assessment of gut, blood and skin

Group Type: EXPERIMENTAL

Doxycycline

Intervention Type: DRUG

Given doxycycline to acne subjects

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Doxycycline

Given doxycycline to acne subjects

Intervention Type: DRUG

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raja K Sivamani, MD MS CAT

Role: PRINCIPAL_INVESTIGATOR

UCDavis

Locations

UC Davis Dept of Dermatology

Sacramento, California, United States

Countries

United States

Other Identifiers

867744

Identifier Type: -

Identifier Source: org_study_id