Analysis of the Microbiome in Rosacea

NCT ID: NCT04108897

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-17
• Study Completion Date: 2027-09-30

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.

Conditions

Rosacea

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Doxycycline 40mg/day

Doxycycline 40mg will be administered once a day per oral for 28 days.

Group Type: EXPERIMENTAL

Doxycycline

Intervention Type: DRUG

The investigators will administer doxycycline to rosacea patients according to the dose of patients' assigned study arm.

Doxycycline 50mg/day

Doxycycline 50mg will be administered once a day per oral for 28 days.

Group Type: EXPERIMENTAL

Doxycycline

Intervention Type: DRUG

The investigators will administer doxycycline to rosacea patients according to the dose of patients' assigned study arm.

Doxycycline 100mg/day

Doxycycline 100mg will be administered once a day per oral for 28 days.

Group Type: EXPERIMENTAL

Doxycycline

Intervention Type: DRUG

The investigators will administer doxycycline to rosacea patients according to the dose of patients' assigned study arm.

Doxycycline 200mg/day

Doxycycline 100mg will be administered twice a day per oral for 28 days.

Group Type: EXPERIMENTAL

Doxycycline

Intervention Type: DRUG

The investigators will administer doxycycline to rosacea patients according to the dose of patients' assigned study arm.

Topical ivermectin(1%)

Topical ivermectin will be applied once a day for 28 days.

Group Type: EXPERIMENTAL

Ivermectin Topical

Intervention Type: DRUG

1% topical ivermectin.

Control

No intervention will be performed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Doxycycline

The investigators will administer doxycycline to rosacea patients according to the dose of patients' assigned study arm.

Intervention Type: DRUG

Ivermectin Topical

1% topical ivermectin.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Chien

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Cutaneous Translational Research Program, Department of Dermatology

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00210816

Identifier Type: -

Identifier Source: org_study_id