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Active, Not Recruiting

NCT Number: NCT04108897

Analysis of the Microbiome in Rosacea

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Cutaneous Translational Research Program, Department of Dermatology

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxycycline

Drug

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

Ivermectin Topical

Drug

1% topical ivermectin.

Primary outcomes

  1. Difference in skin and gut microbiome between rosacea and control

    Time frame: 2 months

    Differences between microbe communities in patients with rosacea and controls without rosacea will be assessed using a 16S rRNA PCR amplification, sequencing and computational phylogenetics.

Secondary outcomes

  1. Change in skin and gut microbiome after 4-week of antimicrobial treatment in rosacea patients

    Time frame: Baseline, 28 days

    Alterations in the gut and skin microbiota of patients with rosacea in response to varying formulations of antimicrobial treatment will be assessed.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Sep 30, 2019
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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