ACTIVE_NOT_RECRUITING

Analysis of the Microbiome in Rosacea

Conditions

Rosacea skin microbiome gut microbiome antimicrobial therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Analysis of the Microbiome in Rosacea

Quick Facts

Study Start:2019-09-17

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04108897

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Anna Chien

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Cutaneous Translational Research Program, Department of Dermatology

Baltimore, Maryland, 21287

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Anna Chien, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-17

Study Completion Date2027-09

Study Record Updates

Study Start Date2019-09-17

Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

rosacea
skin microbiome
gut microbiome
antimicrobial therapy

Additional Relevant MeSH Terms

Rosacea