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Antibiotic

Microbiome Analysis for Rosacea

Phase < 1
Recruiting
Led By Anna Chien
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be over the age of 18 years old.
Participants must have the ability to understand and communicate with the investigator.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights

Study Summary

This trial found that the skin and gut microbiome of rosacea patients differs from individuals without rosacea. They also found that the microbiome suffers from unique derangements in rosacea patients following antibiotic therapy.

Who is the study for?
Adults over 18 with moderate-to-severe erythematotelangiectatic or papulopustular rosacea, or those without rosacea for control. Must understand the study and follow its rules. Can't join if they've had major GI surgery, bleeding disorders, recent facial treatments, certain drug use in past weeks, known allergies to trial medications, chronic diseases like diabetes or immunodeficiency, excessive scarring tendencies, are pregnant or have significant hair growth affecting evaluation.Check my eligibility
What is being tested?
The trial is studying how two treatments—topical Ivermectin and oral Doxycycline—affect the skin and gut microbiome in people with rosacea compared to those without it. It uses DNA sequencing techniques to identify changes in microbial communities after treatment.See study design
What are the potential side effects?
Possible side effects include skin irritation from Ivermectin and digestive upset from Doxycycline. Allergic reactions could occur for those sensitive to these drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 years old.
Select...
I can understand and communicate with my doctor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in skin and gut microbiome between rosacea and control
Secondary outcome measures
Change in skin and gut microbiome after 4-week of antimicrobial treatment in rosacea patients

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Topical ivermectin(1%)Experimental Treatment1 Intervention
Topical ivermectin will be applied once a day for 28 days.
Group II: Doxycycline 50mg/dayExperimental Treatment1 Intervention
Doxycycline 50mg will be administered once a day per oral for 28 days.
Group III: Doxycycline 40mg/dayExperimental Treatment1 Intervention
Doxycycline 40mg will be administered once a day per oral for 28 days.
Group IV: Doxycycline 200mg/dayExperimental Treatment1 Intervention
Doxycycline 100mg will be administered twice a day per oral for 28 days.
Group V: Doxycycline 100mg/dayExperimental Treatment1 Intervention
Doxycycline 100mg will be administered once a day per oral for 28 days.
Group VI: ControlActive Control1 Intervention
No intervention will be performed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxycycline
2008
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,263 Previous Clinical Trials
14,823,015 Total Patients Enrolled
1 Trials studying Rosacea
8 Patients Enrolled for Rosacea
Anna ChienPrincipal InvestigatorJohns Hopkins University
3 Previous Clinical Trials
129 Total Patients Enrolled

Media Library

Doxycycline (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04108897 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health conditions is Ivermectin Topical most often utilized to treat?

"Ivermectin Topical is frequently used for the remedying of severe acne, however it has also been known to provide relief from diseases like trachoma and Klebsiella infections."

Answered by AI

Is there an opportunity to enroll in this research program?

"This medical study is hunting for 150 individuals over 18 and under 99 with or without rosacea. A few prerequisites must be fulfilled by all participants, such as the capability to comprehend and speak with their doctor, a willingness to follow protocol guidelines, and providing written authorization of agreement. Additionally, those that have been diagnosed with moderate-to-severe erythematotelangiectatic or papulopustular rosacea are also welcome."

Answered by AI

Is enrollment currently open for this research project?

"The most up-to-date information on clinicaltrials.gov states that this research study is searching for participants, and has been actively recruiting since its inception in September of 2019. The data was last refreshed on June 28th 2022."

Answered by AI

Does the age requirement of this medical study extend beyond 20 years old?

"This research is open to individuals older than 18 years and younger than 99."

Answered by AI

How many individuals are currently participating in this trial?

"Indeed, the information available on clinicaltrials.gov attests to this medical experiment's current status as an active recruitment centre. Initially posted on September 17th 2019, it was last updated June 28th 2022 and is currently looking for 150 participants at a single site."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
Pennsylvania
New Jersey
How old are they?
18 - 65
What site did they apply to?
Cutaneous Translational Research Program, Department of Dermatology
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have suffered from rosacea since early 20’s turning 55, have Medicare an no new treatments have been available to me for 30 years.
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. Cutaneous Translational Research Program, Department of Dermatology: < 24 hours
Average response time
  • < 1 Day
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Analysis of the Microbiome in Rosacea
2019. "Analysis of the Microbiome in Rosacea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04108897.
All > Rosacea > Microbiome
~10 spots leftby Sep 2024
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