Analysis of the Microbiome in Rosacea

NCT04108897 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: IRB00210816
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

rosacea; skin microbiome; gut microbiome; antimicrobial therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  2 months

Secondary Outcomes (1)

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

  Baseline, 28 days

Study Arms (6)

Doxycycline 40mg/day

EXPERIMENTAL

Doxycycline 40mg will be administered once a day per oral for 28 days.

Drug: Doxycycline

Doxycycline 50mg/day

EXPERIMENTAL

Doxycycline 50mg will be administered once a day per oral for 28 days.

Drug: Doxycycline

Doxycycline 100mg/day

EXPERIMENTAL

Doxycycline 100mg will be administered once a day per oral for 28 days.

Drug: Doxycycline

Doxycycline 200mg/day

EXPERIMENTAL

Doxycycline 100mg will be administered twice a day per oral for 28 days.

Drug: Doxycycline

Topical ivermectin(1%)

EXPERIMENTAL

Topical ivermectin will be applied once a day for 28 days.

Drug: Ivermectin Topical

Control

NO INTERVENTION

No intervention will be performed.

Interventions

Doxycycline DRUG

The investigators will administer doxycycline to rosacea patients according to the dose of patients' assigned study arm.

Doxycycline 100mg/day; Doxycycline 200mg/day; Doxycycline 40mg/day; Doxycycline 50mg/day

Ivermectin Topical DRUG

1% topical ivermectin.

Topical ivermectin(1%)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Cutaneous Translational Research Program, Department of Dermatology

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

Doxycycline; Ivermectin

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Macrolides; Polyketides; Lactones

Study Officials

• Anna Chien

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Study Start: September 17, 2019
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

US (1)