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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
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I am over 18 years old.
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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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Rosacea, particularly those involving antimicrobial therapy, work by targeting the altered skin and gut microbiota associated with the condition. Antibiotics such as tetracycline and metronidazole reduce inflammation and bacterial overgrowth, which can alleviate symptoms like redness, swelling, and pustules. These treatments are crucial for Rosacea patients because they help restore a healthier balance of microbes, potentially reducing flare-ups and improving overall skin health.
Effect of combined systemic antimicrobial therapy and mechanical plaque control in patients with recurrent periodontal disease.Effect of the local probiotics in the therapy of periodontitis A randomized prospective study.An Insight into Acute Pericoronitis and the Need for an Evidence-Based Standard of Care.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,274 Previous Clinical Trials
14,840,368 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
~8 spots leftby Sep 2024
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