Analysis of the Microbiome in Rosacea

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04108897

Collaborator

(none)

150

Enrollment

Location

Arms

47.5

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rosacea	Drug: Doxycycline Drug: Ivermectin Topical	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Analysis of the Microbiome in Rosacea

Actual Study Start Date :

Sep 17, 2019

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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