Analysis of the Microbiome in Rosacea

Early Phase 1

Recruiting

• Conditions: Rosacea
• Interventions: Drug: Ivermectin Topical; Drug: Doxycycline

• Registration Number: NCT04108897
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-17
• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical ivermectin(1%)	Ivermectin Topical	Topical ivermectin will be applied once a day for 28 days.
Doxycycline 50mg/day	Doxycycline	Doxycycline 50mg will be administered once a day per oral for 28 days.
Doxycycline 40mg/day	Doxycycline	Doxycycline 40mg will be administered once a day per oral for 28 days.
Doxycycline 100mg/day	Doxycycline	Doxycycline 100mg will be administered once a day per oral for 28 days.
Doxycycline 200mg/day	Doxycycline	Doxycycline 100mg will be administered twice a day per oral for 28 days.

Primary Outcome Measures

Name	Time	Method
Difference in skin and gut microbiome between rosacea and control	2 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cutaneous Translational Research Program, Department of Dermatology; 🇺🇸 Baltimore, Maryland, United States