What side effects are associated with this type of intervention?

Common treatments for rosacea, particularly those involving antibiotics, can lead to significant alterations in the skin and gut microbiome. These changes may result in gastrointestinal disturbances, development of antibiotic resistance, and disruption of normal microbial flora. Additionally, there is a risk of secondary infections, such as Clostridioides difficile, due to the imbalance in microbial communities.

What prior FDA approvals exist?

The FDA has approved several treatments for Rosacea that include antimicrobial agents, which can alter the microbiota composition. These treatments include topical antibiotics like metronidazole and oral antibiotics such as doxycycline. These medications help reduce inflammation and bacterial load, which are key factors in managing Rosacea symptoms. The study of antimicrobial treatments in altering microbiota composition aligns with these approved therapies, as they also target the microbial imbalance associated with Rosacea.

What other types of research exist?

Promising novel alternatives to antimicrobial treatment for rosacea patients include: 1) Topical treatments such as ivermectin and brimonidine, which reduce inflammation and erythema without significantly altering the microbiota. 2) Laser and light therapies, including pulsed dye laser (PDL) and intense pulsed light (IPL), which target vascular components of rosacea. 3) Systemic treatments like low-dose isotretinoin, which can reduce symptoms with minimal impact on the microbiome. These alternatives offer effective management of rosacea while preserving the natural microbiota.

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Antibiotic

Microbiome Analysis for Rosacea

Q: What is the mechanism of action of this treatment?

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.

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.

Must not have

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 known bleeding disorders.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months

Awards & highlights

No Placebo-Only Group

Summary

This trial examines how different antimicrobial treatments affect the skin and gut bacteria in people with moderate to severe rosacea. It aims to see if these treatments can help by changing the bacteria that live on the skin and in the gut.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't used strong medications for skin issues recently.

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I have a known bleeding disorder.

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I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in skin and gut microbiome between rosacea and control

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2650

0 / 5Eligibility criteria met

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.