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Active, not recruitingNCT04108897Updated Jun 8, 2026

Analysis of the Microbiome in Rosacea

An Early Phase 1 interventional study of Doxycycline and Ivermectin Topical in Rosacea, sponsored by Johns Hopkins University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by Johns Hopkins University · Early Phase 1, Interventional, and Basic science

Phase
Early Phase 1
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Rosacea

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Keywords

  • rosacea
  • skin microbiome
  • gut microbiome
  • antimicrobial therapy
03

In context

Rosacea

233 studies on the registry are indexed under Rosacea; 23 are open to participants now.

This study's planned enrollment of 150 is above the median of 61 across 200 interventional studies indexed under Rosacea.

Browse Rosacea studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.

Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  • Subjects unable to provide .
  • 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//other anti- inflammatory medications on the face, 8 weeks for systemic antibiotics/steroids/other 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 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Doxycycline 40mg/day

    Doxycycline 40mg will be administered once a day per oral for 28 days.

    Drug: Doxycycline

  • Experimental
    Doxycycline 50mg/day

    Doxycycline 50mg will be administered once a day per oral for 28 days.

    Drug: Doxycycline

  • Experimental
    Doxycycline 100mg/day

    Doxycycline 100mg will be administered once a day per oral for 28 days.

    Drug: Doxycycline

  • Experimental
    Doxycycline 200mg/day

    Doxycycline 100mg will be administered twice a day per oral for 28 days.

    Drug: Doxycycline

  • Experimental
    Topical ivermectin(1%)

    Topical ivermectin will be applied once a day for 28 days.

    Drug: Ivermectin Topical

  • No intervention
    Control

    No intervention will be performed.

Interventions

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

  • DrugIvermectin Topical

    1% topical ivermectin.

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 2 months

Secondary outcomes

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

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

    Time frame: Baseline, 28 days

07

Study locations

1 site
  • Cutaneous Translational Research Program, Department of Dermatology
    Baltimore, Maryland 21287, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04108897
Responsible party
Sponsor
First posted
Sep 30, 2019
Start date
Sep 17, 2019
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Jun 8, 2026

Study contacts

Anna Chien
principal investigator · Johns Hopkins University

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Doxycycline

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