RosaceaEarly Phase 1NCT04108897
Analysis of the Microbiome in Rosacea
A Early Phase 1 study testing Doxycycline and Ivermectin Topical in people with Rosacea, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Rosacea
- What is being tested?
- Doxycycline and Ivermectin Topical
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2019to Sep 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cutaneous Translational Research Program, Department of Dermatology
Baltimore, Maryland, 21287
About this study
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.
- Conditions
- Rosacea
- Being tested
- Doxycycline, Ivermectin Topical
- Keywords
- rosacea, skin microbiome, gut microbiome, antimicrobial therapy
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
The investigators will administer doxycycline to rosacea patients according to the dose of patients' assigned study arm.
Ivermectin TopicalDrug
1% topical ivermectin.
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline 40mg/day | Experimental | Doxycycline 40mg will be administered once a day per oral for 28 days. Receives: Drug: Doxycycline |
| Doxycycline 50mg/day | Experimental | Doxycycline 50mg will be administered once a day per oral for 28 days. Receives: Drug: Doxycycline |
| Doxycycline 100mg/day | Experimental | Doxycycline 100mg will be administered once a day per oral for 28 days. Receives: Drug: Doxycycline |
| Doxycycline 200mg/day | Experimental | Doxycycline 100mg will be administered twice a day per oral for 28 days. Receives: Drug: Doxycycline |
| Topical ivermectin(1%) | Experimental | Topical ivermectin will be applied once a day for 28 days. Receives: Drug: Ivermectin Topical |
| Control | No intervention | No intervention will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start17 Sep 2019
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Chien, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108897
- Sponsor's protocol ID
- IRB00210816
- Status last verified
- Jun 2026
- First submitted
- 26 Sep 2019
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Microbiome in Rosacea
- ClinicalTrials.gov ID
- NCT04108897
- Acronym / sponsor ID
- IRB00210816
- Conditions
- Rosacea
- Keywords
- rosacea, skin microbiome, gut microbiome, antimicrobial therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Doxycycline 40mg/day | Experimental | Drug: DoxycyclineDoxycycline 40mg will be administered once a day per oral for 28 days. |
| Doxycycline 50mg/day | Experimental | Drug: DoxycyclineDoxycycline 50mg will be administered once a day per oral for 28 days. |
| Doxycycline 100mg/day | Experimental | Drug: DoxycyclineDoxycycline 100mg will be administered once a day per oral for 28 days. |
| Doxycycline 200mg/day | Experimental | Drug: DoxycyclineDoxycycline 100mg will be administered twice a day per oral for 28 days. |
| Topical ivermectin(1%) | Experimental | Drug: Ivermectin TopicalTopical ivermectin will be applied once a day for 28 days. |
| Control | No intervention | –No intervention will be performed. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclineThe investigators will administer doxycycline to rosacea patients according to the dose of patients' assigned study arm. | Drug | Doxycycline 100mg/day, Doxycycline 200mg/day, Doxycycline 40mg/day, Doxycycline 50mg/day |
| Ivermectin Topical1% topical ivermectin. | Drug | Topical ivermectin(1%) |
Primary outcome
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.
1 secondary outcome
Change in skin and gut microbiome after 4-week of antimicrobial treatment in rosacea patients
Time frame: Baseline, 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Chien principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Doxycycline and Ivermectin Topical in people with Rosacea, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in skin and gut microbiome between rosacea and control (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.