Status:
ACTIVE_NOT_RECRUITING
Analysis of the Microbiome in Rosacea
Lead Sponsor:
Johns Hopkins University
Conditions:
Rosacea
Eligibility:
All Genders
18-99 years
Phase:
EARLY_PHASE1
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. Thi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04108897
Start Date
September 17 2019
End Date
September 1 2027
Last Update
June 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cutaneous Translational Research Program, Department of Dermatology
Baltimore, Maryland, United States, 21287