150 Participants Needed

Microbiome Analysis for Rosacea

RW
Overseen ByRuizhi Wang
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before joining. You must not have used topical antibiotics, steroids, or other anti-inflammatory medications on your face for 4 weeks, and systemic antibiotics, steroids, or other immunosuppressive agents for 8 weeks before starting. Additionally, you should not have taken proton pump inhibitors, H2 receptor antagonists, laxatives, antidiarrheal medication, NSAIDs, or antacids within 2 weeks prior to enrollment.

What data supports the effectiveness of the drug for treating rosacea?

Research shows that using doxycycline, an oral antibiotic, can reduce the severity of rosacea symptoms by altering the skin's bacterial makeup. Additionally, combining topical ivermectin with doxycycline may target different inflammation pathways, potentially improving treatment outcomes for rosacea.12345

Is the treatment safe for humans?

The treatment using doxycycline and ivermectin for rosacea is generally safe, with most side effects being mild or moderate, such as diarrhea, nausea, and headache. In studies, only a small percentage of participants experienced these side effects.12678

How is the drug combination of Doxycycline and Ivermectin unique for treating rosacea?

The combination of oral doxycycline and topical ivermectin is unique for treating rosacea because it targets different inflammatory pathways involved in the condition. Doxycycline works systemically to reduce inflammation, while ivermectin is applied directly to the skin to target inflammatory lesions, offering a complementary approach that may be more effective than using either treatment alone.23459

What is the purpose of this trial?

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.

Research Team

AC

Anna Chien

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 years old.
I can understand and communicate with my doctor.
Participants must be willing and comply with the requirements of the protocol.
See 2 more

Exclusion Criteria

I am willing to not wash my face or wear makeup for 24 hours before the sampling visit.
I haven't used strong medications for skin issues recently.
I have a known bleeding disorder.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive varying formulations of doxycycline or topical ivermectin for 28 days

4 weeks
1 visit (in-person) at baseline

Follow-up

Participants are monitored for changes in skin and gut microbiome after treatment

4 weeks
1 visit (in-person) at 2 months

Treatment Details

Interventions

  • Doxycycline
  • Ivermectin Topical
Trial Overview 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.
Participant Groups
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.

Doxycycline is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Doxycycline for:
  • Acne
  • Bacterial infections
  • Chlamydia
  • Gonorrhea
  • Lyme disease
  • Malaria
  • Pneumonia
  • Rosacea
  • Urinary tract infections
🇪🇺
Approved in European Union as Doxycycline for:
  • Acne
  • Bacterial infections
  • Chlamydia
  • Gonorrhea
  • Lyme disease
  • Malaria
  • Pneumonia
  • Rosacea
  • Urinary tract infections
🇨🇦
Approved in Canada as Doxycycline for:
  • Acne
  • Bacterial infections
  • Chlamydia
  • Gonorrhea
  • Lyme disease
  • Malaria
  • Pneumonia
  • Rosacea
  • Urinary tract infections
🇯🇵
Approved in Japan as Doxycycline for:
  • Acne
  • Bacterial infections
  • Chlamydia
  • Gonorrhea
  • Lyme disease
  • Malaria
  • Pneumonia
  • Rosacea
  • Urinary tract infections

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Findings from Research

In a study involving 40 patients, the combination of subantimicrobial doses of doxycycline (20 mg twice daily) with topical metronidazole significantly reduced inflammatory lesions in rosacea compared to metronidazole alone, with results observed as early as week 4.
The benefits of doxycycline were maintained even after transitioning to monotherapy, suggesting it could be an effective long-term maintenance treatment for rosacea.
A randomized, double-blind, placebo-controlled trial of the combined effect of doxycycline hyclate 20-mg tablets and metronidazole 0.75% topical lotion in the treatment of rosacea.Sanchez, J., Somolinos, AL., Almodóvar, PI., et al.[2013]
Topical ivermectin cream and oral doxycycline are both effective treatments for papulopustular rosacea, targeting different inflammatory pathways, which suggests that using them together could enhance treatment outcomes.
The combination of these two therapies is proposed as a promising first-line approach for managing rosacea, as they complement each other's mechanisms of action to address the various signs and symptoms of the condition.
Topical Ivermectin 10 mg/g and Oral Doxycycline 40 mg Modified-Release: Current Evidence on the Complementary Use of Anti-Inflammatory Rosacea Treatments.Steinhoff, M., Vocanson, M., Voegel, JJ., et al.[2018]
A study of 12 rosacea patients showed that oral doxycycline treatment for six weeks effectively reduced the severity of rosacea symptoms, indicating its efficacy as a treatment option.
The treatment altered the skin microbiota by increasing the abundance of Weissella confusa, but did not significantly change overall bacterial diversity, suggesting that while antibiotics can impact specific bacteria, they may not drastically shift the entire microbiome.
Characterization and Analysis of the Skin Microbiota in Rosacea: Impact of Systemic Antibiotics.Woo, YR., Lee, SH., Cho, SH., et al.[2020]

References

A randomized, double-blind, placebo-controlled trial of the combined effect of doxycycline hyclate 20-mg tablets and metronidazole 0.75% topical lotion in the treatment of rosacea. [2013]
Topical Ivermectin 10 mg/g and Oral Doxycycline 40 mg Modified-Release: Current Evidence on the Complementary Use of Anti-Inflammatory Rosacea Treatments. [2018]
Characterization and Analysis of the Skin Microbiota in Rosacea: Impact of Systemic Antibiotics. [2020]
Microbiota of Demodex mites from rosacea patients and controls. [2022]
Effect on the Skin Microbiota of Oral Minocycline for Rosacea. [2023]
An open-label, community-based, 12-week assessment of the effectiveness and safety of monotherapy with doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads). [2013]
Effectiveness and safety of doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads) once daily as add-on therapy to existing topical regimens for the treatment of papulopustular rosacea: results from a community-based trial. [2015]
Efficacy of topical azelaic acid (AzA) gel 15% plus oral doxycycline 40 mg versus metronidazole gel 1% plus oral doxycycline 40 mg in mild-to-moderate papulopustular rosacea. [2014]
Ocular Rosacea microBiome Study (ORBS)-sub-microbial versus antibiotic dosing of doxycycline versus placebo in treatment of symptomatic ocular rosacea: study protocol for a parallel-arm randomized clinical trial. [2022]
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