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Analysis of the Microbiome in Rosacea

Primary Purpose

Rosacea

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Doxycycline

Ivermectin Topical

About this trial

This is an interventional basic science trial for Rosacea focused on measuring rosacea, skin microbiome, gut microbiome, antimicrobial therapy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Cutaneous Translational Research Program, Department of DermatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

No Intervention

Arm Label

Doxycycline 40mg/day

Doxycycline 50mg/day

Doxycycline 100mg/day

Doxycycline 200mg/day

Topical ivermectin(1%)

Control

Arm Description

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

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

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

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

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

No intervention will be performed.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Alterations in the gut and skin microbiota of patients with rosacea in response to varying formulations of antimicrobial treatment will be assessed.

Full Information

NCT ID

NCT04108897

First Posted

September 26, 2019

Last Updated

June 8, 2023

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT04108897

Brief Title

Analysis of the Microbiome in Rosacea

Official Title

Analysis of the Microbiome in Rosacea

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 17, 2019 (Actual)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rosacea

Keywords

rosacea, skin microbiome, gut microbiome, antimicrobial therapy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Doxycycline 40mg/day

Arm Type

Experimental

Arm Description

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

Arm Title

Doxycycline 50mg/day

Arm Type

Experimental

Arm Description

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

Arm Title

Doxycycline 100mg/day

Arm Type

Experimental

Arm Description

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

Arm Title

Doxycycline 200mg/day

Arm Type

Experimental

Arm Description

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

Arm Title

Topical ivermectin(1%)

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Arm Description

No intervention will be performed.

Intervention Type

Drug

Intervention Name(s)

Doxycycline

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ivermectin Topical

Intervention Description

1% topical ivermectin.

Primary Outcome Measure Information:

Title

Difference in skin and gut microbiome between rosacea and control

Description

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.

Time Frame

2 months

Secondary Outcome Measure Information:

Title

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

Description

Alterations in the gut and skin microbiota of patients with rosacea in response to varying formulations of antimicrobial treatment will be assessed.

Time Frame

Baseline, 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ruizhi Wang

Phone

410-502-7546

rwang@jhmi.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anna Chien

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cutaneous Translational Research Program, Department of Dermatology

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ruizhi Wang

Phone

410-208-7546

rwang@jhmi.edu

12. IPD Sharing Statement

Learn more about this trial

Analysis of the Microbiome in Rosacea

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