Analysis of the Microbiome in Rosacea

The skin and gut microbiome of rosacea patients differs from individuals without rosacea and that the microbiome suffers from unique derangements in rosacea patients following antibiotic therapy.

This study was proposed to examine microbial signatures of the skin and gut microbiome in patients with moderate to severe rosacea and to identify differences between microbe communities in patients with rosacea and volunteers without rosacea using 16S ribosomal ribonucleic acid (rRNA) polymerase chain reaction (PCR) amplification, sequencing and computational phylogenetics and to assess alterations in the gut and skin microbiota of patients with moderate to severe rosacea in response to varying formulations of antimicrobial treatment.

Study Overview

• Status: Recruiting
• Conditions: Rosacea
• Intervention / Treatment: Drug: Doxycycline; Drug: Ivermectin Topical

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Ruizhi Wang; Phone Number: 410-502-7546; Email: rwang@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Cutaneous Translational Research Program, Department of Dermatology
      • Contact: Ruizhi Wang; Phone Number: 410-208-7546; Email: rwang@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants must be over the age of 18 years old.
• Participants must have a current diagnosis of moderate-to-severe erythematotelangiectatic or papulopustular rosacea or free of rosacea to serve as control.
• Participants must have the ability to understand and communicate with the investigator.
• Participants must be willing and comply with the requirements of the protocol.
• Participants must provide written informed consent

Exclusion Criteria:

• Subjects unable to provide informed consent.
• Subjects with significant medical history or concurrent illness that the investigator feels are not safe for study participation.
• Recently treated (4 weeks for topical antibiotics/steroids/other anti- inflammatory medications on the face, 8 weeks for systemic antibiotics/steroids/other immunosuppressive agents) or current (skin) diseases that would affect clinical evaluation and skin sampling.
• Subjects with a history of facial surgeries and cosmetic procedures (i.e. laser therapy, resurfacing, dermal fillers, and deep chemical peels) within 6 months.
• Subjects with facial features (i.e. significant hair growth) that would affect clinical evaluation and skin sampling.
• Participants with a history of chronic gastrointestinal disease, diabetes mellitus, cardiac disease or immunodeficiency disease.
• Intake of proton pump inhibitors, H2 receptor antagonists, laxatives, or antidiarrheal medication, NSAIDs, or antacids within 2 weeks prior to enrollment.
• Participants with a history of major surgery of the GI tract (5 years).
• Participants with a known hypersensitivity to tetracyclines or doxycycline or topical ivermectin
• Subjects unwilling to avoid facial washing for 24 hours prior to sampling and to come to sampling visit without make-up.
• Subjects with known allergy to lidocaine and epinephrine.
• Subjects with known bleeding disorders.
• Subjects with a history of keloids or excessive scarring.
• Pregnant subjects. Self-reporting will be used to determine whether a patient is pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Doxycycline 40mg/day; Doxycycline 40mg will be administered once a day per oral for 28 days.	Drug: Doxycycline; The investigators will administer doxycycline to rosacea patients according to the dose of patients' assigned study arm.
Experimental: Doxycycline 50mg/day; Doxycycline 50mg will be administered once a day per oral for 28 days.	Drug: Doxycycline; The investigators will administer doxycycline to rosacea patients according to the dose of patients' assigned study arm.
Experimental: Doxycycline 100mg/day; Doxycycline 100mg will be administered once a day per oral for 28 days.	Drug: Doxycycline; The investigators will administer doxycycline to rosacea patients according to the dose of patients' assigned study arm.
Experimental: Doxycycline 200mg/day; Doxycycline 100mg will be administered twice a day per oral for 28 days.	Drug: Doxycycline; The investigators will administer doxycycline to rosacea patients according to the dose of patients' assigned study arm.
Experimental: Topical ivermectin(1%); Topical ivermectin will be applied once a day for 28 days.	Drug: Ivermectin Topical; 1% topical ivermectin.
No Intervention: Control; No intervention will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in skin and gut microbiome between rosacea and control	Differences between microbe communities in patients with rosacea and controls without rosacea will be assessed using a 16S rRNA PCR amplification, sequencing and computational phylogenetics.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in skin and gut microbiome after 4-week of antimicrobial treatment in rosacea patients	Alterations in the gut and skin microbiota of patients with rosacea in response to varying formulations of antimicrobial treatment will be assessed.	Baseline, 28 days

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Anna Chien, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2019
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (Actual): September 30, 2019

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: rosacea; gut microbiome; antimicrobial therapy; skin microbiome
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline; Ivermectin
• Other Study ID Numbers: IRB00210816

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes