Active — Not RecruitingEarly Phase 1

Analysis of the Microbiome in Rosacea

United States150 participantsStarted 2019-09-17

Plain-language 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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. * Pa…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference in skin and gut microbiome between rosacea and control

Timeframe: 2 months

Trial details

NCT IDNCT04108897

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09

View on ClinicalTrials.gov More Rosacea trials