Clinical trial NCT03655197: Lipidome and Microbiome Profile of the Eye in Rosacea
Official title: Lipidome and Microbiome Profile of the Eye in Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Rosacea
Ocular Rosacea
Cutaneous Rosacea
Keywords: Microbiome
Lipidome
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Healthy Subjects-No Intervention Ocular Rosacea Subjects-Mandatory Doxycycline Intervention Cutaneous Rosacea Subjects-Optional Doxycycline Intervention
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lipidome Change in Diversity
timeFrame: 1-5 weeks
measure: Microbiome Change in Diversity
timeFrame: 1-5 weeks
measure: Lipidome Change in Quantity
timeFrame: 1-5 weeks
measure: Microbiome Change in Quantity
timeFrame: 1-5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California-Davis, Department of Dermatology
state: California
Study officials:
affiliation: UC Davis, Department of Dermatology
name: Raja Sivamani, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Davis, Department of Ophthalmology
name: Mark Mannis, MD
role: PRINCIPAL_INVESTIGATOR
References: