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Trial record 80 of 103 for:    IVERMECTIN

Analysis of the Microbiome in Rosacea

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ClinicalTrials.gov Identifier: NCT04108897
Recruitment Status : Active, not recruiting
First Posted : September 30, 2019
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.


Condition or disease Intervention/treatment Phase
Rosacea Drug: Doxycycline Drug: Ivermectin Topical Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Analysis of the Microbiome in Rosacea
Actual Study Start Date : September 17, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: Doxycycline 40mg/day
Doxycycline 40mg will be administered once a day per oral for 28 days.
Drug: Doxycycline
The investigators will administer doxycycline to rosacea patients according to the dose of patients' assigned study arm.

Experimental: Doxycycline 50mg/day
Doxycycline 50mg will be administered once a day per oral for 28 days.
Drug: Doxycycline
The investigators will administer doxycycline to rosacea patients according to the dose of patients' assigned study arm.

Experimental: Doxycycline 100mg/day
Doxycycline 100mg will be administered once a day per oral for 28 days.
Drug: Doxycycline
The investigators will administer doxycycline to rosacea patients according to the dose of patients' assigned study arm.

Experimental: Doxycycline 200mg/day
Doxycycline 100mg will be administered twice a day per oral for 28 days.
Drug: Doxycycline
The investigators will administer doxycycline to rosacea patients according to the dose of patients' assigned study arm.

Experimental: Topical ivermectin(1%)
Topical ivermectin will be applied once a day for 28 days.
Drug: Ivermectin Topical
1% topical ivermectin.

No Intervention: Control
No intervention will be performed.



Primary Outcome Measures :
  1. Difference in skin and gut microbiome between rosacea and control [ Time Frame: 2 months ]
    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 :
  1. Change in skin and gut microbiome after 4-week of antimicrobial treatment in rosacea patients [ Time Frame: Baseline, 28 days ]
    Alterations in the gut and skin microbiota of patients with rosacea in response to varying formulations of antimicrobial treatment will be assessed.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04108897


Locations
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United States, Maryland
Cutaneous Translational Research Program, Department of Dermatology
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Anna Chien Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04108897     History of Changes
Other Study ID Numbers: IRB00210816
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Johns Hopkins University:
rosacea
skin microbiome
gut microbiome
antimicrobial therapy
Additional relevant MeSH terms:
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Rosacea
Skin Diseases
Doxycycline
Ivermectin
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents