Lipidome and Microbiome Profile of Acne

NCT02713607 | Active Not Recruiting Phase 1

• 1 other identifier: 867744
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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

  2 years

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

  2 years

Study Arms (2)

doxycycline

EXPERIMENTAL

Given doxycycline and assessment of gut, blood and skin

Drug: Doxycycline

Control

NO INTERVENTION

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

Interventions

Doxycycline DRUG

Given doxycycline to acne subjects

doxycycline

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Dept of Dermatology

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Raja K Sivamani, MD MS CAT

  UCDavis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 21, 2016
• Study Start: March 1, 2016
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)