Clinical trial NCT04108897: Analysis of the Microbiome in Rosacea
Official title: Analysis of the Microbiome in Rosacea
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Rosacea
Keywords: rosacea
skin microbiome
gut microbiome
antimicrobial therapy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Difference in skin and gut microbiome between rosacea and control
timeFrame: 2 months
Secondary outcomes:
measure: Change in skin and gut microbiome after 4-week of antimicrobial treatment in rosacea patients
timeFrame: Baseline, 28 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Cutaneous Translational Research Program, Department of Dermatology
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Anna Chien
role: PRINCIPAL_INVESTIGATOR
References: