Examining the microbiome in patients with rosacea
Analysis of the Microbiome in Rosacea
This study is testing how the bacteria on the skin and in the gut of people with moderate to severe rosacea differ from those of healthy individuals and how these bacteria change with different treatments.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04108897 on ClinicalTrials.gov |
What this trial studies
This study investigates the differences in skin and gut microbiomes between patients with moderate to severe rosacea and healthy volunteers. It utilizes advanced techniques such as 16S rRNA PCR amplification and sequencing to analyze microbial communities. The study also aims to assess how these microbiomes change in response to various antimicrobial treatments, including doxycycline and topical ivermectin. By understanding these microbial signatures, the research seeks to uncover potential therapeutic targets for rosacea management.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a diagnosis of moderate to severe rosacea or healthy individuals to serve as controls.
Not a fit: Patients with significant medical histories or concurrent illnesses that may compromise their safety during the study may not benefit.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients suffering from rosacea.
How similar studies have performed: Other studies have shown promising results in understanding the role of the microbiome in skin conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- Cutaneous Translational Research Program, Department of Dermatology — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Anna Chien — Johns Hopkins University
- Study coordinator: Ruizhi Wang
- Email: rwang@jhmi.edu
- Phone: 410-502-7546
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.