Skip to content

Lipidome and Microbiome Profile of the Eye in Rosacea

Lipidome and Microbiome Profile of the Eye in Rosacea

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03655197
Enrollment
30
Registered
2018-08-31
Start date
2017-11-02
Completion date
2021-07-01
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Rosacea, Ocular Rosacea, Rosacea

Keywords

Microbiome, Lipidome

Brief summary

The question that the investigators aim to address in this proposal is how the local lipid mediator profiles of ceramides and eicosanoids are altered in cutaneous and ocular rosacea and how antibiotics alter the lipidome. The investigators also seek to understand how the microbiome is changed in those with and without rosacea, and how the microbiome is altered in those with rosacea. Understanding how the lipidome is modulated in rosacea with antibiotic treatment will serve as the first step in targeting therapies toward directly altering the lipidome to reduce inflammation and ultimately reduce the use of antibiotics.

Detailed description

Rosacea is a common condition that has multiple subtypes that exhibit inflammation and deficits in the skin/eye barrier function. Cutaneous rosacea is estimated to have an incidence of 10-22% while the prevalence of ocular rosacea ranging from 6-72%. Although rosacea is not an infection, antibiotics are widely used as first-line therapy due to their anti-inflammatory and skin-barrier function supporting effects. The most common class of antibiotics used are the tetracyclines, such as doxycycline and minocycline. With the emergence of community acquired methicillin resistant Staphylococcus aureus (MRSA) as well as macrolide resistant Streptococci and Staphylococci, there is growing concern for the widespread use of antibiotics for non-infectious conditions. The current clinical gap in practice is that there are few alternative therapies to antibiotics and this is partly due to our lack of understanding of what leads to the impaired skin/eye barrier and inflammation in rosacea. Few lipid-based studies have been performed in rosacea but there is early evidence for the importance in the lipidome to rosacea. The sebum in those with papulopustular rosacea was identified to have an abnormal profile to their sebum with a deficiency in long chain saturated fatty acids6 that correlates with the deficient skin barrier that is seen in rosacea. Treatment with minocycline was shown to restore skin barrier function in papulopustular rosacea but no lipid profile related measures were performed. Moreover, no studies have evaluated the role of other lipid mediators that are closely associated with the skin barrier and inflammation such as the ceramides and the eicosanoids. The question that the investigators aim to address in this proposal is how the local lipid mediator profiles of ceramides and eicosanoids are altered in cutaneous and ocular rosacea and how antibiotics alter the lipidome. The investigators also seek to understand how the microbiome is changed in those with and without rosacea, and how the microbiome is altered in those with rosacea. Understanding how the lipidome is modulated in rosacea with antibiotic treatment will serve as the first step in targeting therapies toward directly altering the lipidome to reduce inflammation and ultimately reduce the use of antibiotics.

Interventions

DRUGDoxycycline

For those participating in the Doxycycline intervention, they will take 100 mg twice daily for 1 month.

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Healthy Subjects-No Intervention Ocular Rosacea Subjects-Mandatory Doxycycline Intervention Cutaneous Rosacea Subjects-Optional Doxycycline Intervention

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

for subjects: * Aged 18 and older * Subjects that meet one of the following criteria: * Healthy subjects without an inflammatory facial rash or an inflammatory eye condition * Subjects diagnosed with ocular rosacea or cutaneous rosacea (papulopustular or erythematotelangiectatic) by either a board-certified dermatologist or ophthalmologist

Exclusion criteria

* Those who are prisoners or cognitively impaired. * Those who have had any change to their hormonal birth control regimen in the last 4 weeks * Systemic antibiotic use in the last four weeks * Allergy or known intolerance to tetracyclines * Those who wear contact lenses * Autoimmune disease such as lupus, dermatomyositis that has cutaneous involvement * Those who are pregnant or may become pregnant

Design outcomes

Primary

MeasureTime frameDescription
Lipidome Change in Diversity1-5 weeksLipid profiles will be assessed, such as inflammatory and non-inflammatory lipid mediators, along with the alpha and beta diversity of the lipidome of the samples. The shifts in diversity of the lipidome will be quantified.
Microbiome Change in Diversity1-5 weeksThe microbiome content and the microbiome between sites on the same patient will be assessed. The assessment will examine what new bacteria becomes present.
Lipidome Change in Quantity1-5 weeksLipid profiles will be assessed, such as inflammatory and non-inflammatory lipid mediators, along with the alpha and beta diversity of the lipidome of the samples. The increase or decrease of inflammatory and non-inflammatory lipid mediators will be quantified.
Microbiome Change in Quantity1-5 weeksThe microbiome content and the microbiome between sites on the same patient will be assessed. The assessment will examine how the previously present bacteria changes in quantity.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026