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ACTIVE NOT RECRUITING

NCT04108897

EARLY_PHASE1

Analysis of the Microbiome in Rosacea

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2019-09-17

Completion Date

2027-09

Last Updated

2025-06-13

Healthy Volunteers

Yes

Conditions

Rosacea

Interventions

DRUG

Doxycycline

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

DRUG

Ivermectin Topical

1% topical ivermectin.

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

Locations (1)

Cutaneous Translational Research Program, Department of Dermatology

Baltimore, Maryland, United States