Lipidome and Microbiome Profile of the Eye in Rosacea

NCT03655197 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 1138313
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Rosacea; Ocular Rosacea; Cutaneous Rosacea

Keywords

Microbiome; Lipidome

Outcome Measures

Primary Outcomes (4)

• Lipidome Change in Diversity

  Lipid 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.

  1-5 weeks

• Microbiome Change in Diversity

  The microbiome content and the microbiome between sites on the same patient will be assessed. The assessment will examine what new bacteria becomes present.

  1-5 weeks

• Lipidome Change in Quantity

  Lipid 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.

  1-5 weeks

• Microbiome Change in Quantity

  The 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.

  1-5 weeks

Study Arms (3)

Healthy Subjects

NO INTERVENTION

Healthy subjects will receive no intervention and will have samples collected only at one visit after Dove soap washout.

Ocular Rosacea Subjects

EXPERIMENTAL

Ocular rosacea subjects will receive mandatory Doxycycline intervention and will have samples collected at two visits, before starting intervention and at the completion of the intervention.

Drug: Doxycycline

Cutaneous Rosacea Subjects

OTHER

Doxycycline intervention is optional for cutaneous rosacea subjects. If they do not participate, samples will only be collected at one visit after Dove soap washout. If they do decide to participate, samples will also be collected after completion of the Doxycycline intervention.

Drug: Doxycycline

Interventions

Doxycycline DRUG

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

Cutaneous Rosacea Subjects; Ocular Rosacea Subjects

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California-Davis, Department of Dermatology

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Raja Sivamani, MD, MS

  UC Davis, Department of Dermatology

  PRINCIPAL INVESTIGATOR

• Mark Mannis, MD

  UC Davis, Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Healthy Subjects-No Intervention Ocular Rosacea Subjects-Mandatory Doxycycline Intervention Cutaneous Rosacea Subjects-Optional Doxycycline Intervention

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 31, 2018
• Study Start: November 2, 2017
• Primary Completion: June 30, 2021
• Study Completion: July 1, 2021
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)