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NCT03018275 · ClinicalTrials.gov registry record · Phase 1

Beginning Assessment of Cutaneous Treatment Efficacy of Roseomonas in Atopic Dermatitis

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
31
Enrollment target

NCT03018275 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 31 participants.

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The verdict

NCT03018275, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
31 participants
Enrollment target

Study Summary

Background: Atopic dermatitis (AD) is a skin disease also called eczema. It is common in children and sometimes gets better on its own. However, chronic AD may cause asthma, food allergies, eye infections, and sleep problems. The cause of AD might be related to bacteria that live on the skin. Researchers want to see if introducing bacteria, R mucosa, from healthy skin onto the skin of someone with AD helps treat the disease. Objective: To test the safety and activity of R mucosa for treating AD. Eligibility: Part 1: People ages 18 and older with AD Part 2: Children ages 3-17 with AD Design: Participants will be screened with: Medical history Physical exam Examination of their AD Blood and urine tests At the baseline visit, participants will have blood tests and photos taken of their skin. They will get a supply of R mucosa and a memory aid to track their doses and record how they are feeling. Part 2 participants guardians will complete questionnaires about their child s AD. Part 1 participants will spray R mucosa on their arm twice per week for 6 weeks. Part 2 guardians will spray it on their child s arm twice per week for 16 weeks. Participants will have follow-up visits to repeat some baseline tests and review their memory aid: Part 1: Six weeks after the baseline visit Part 2: Four times over 16 weeks; then 2 or 3 times for 1 year Participants will be called or emailed to discuss how they are feeling: Part 1: About 30 days after their last visit Part 2: About every 10 days between visits

Interventions

  • BIOLOGICAL Roseomonas mucosa

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2017-04-20
Est. Completion 2019-10-11
Phase Phase 1

What the Registry Record Tells You About NCT03018275

The ClinicalTrials.gov registry entry for NCT03018275 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Roseomonas mucosa is the first listed.

NCT03018275 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03018275 about?

NCT03018275 is a clinical study titled "Beginning Assessment of Cutaneous Treatment Efficacy of Roseomonas in Atopic Dermatitis". Background: Atopic dermatitis (AD) is a skin disease also called eczema. It is common in children and sometimes gets better on its own. However, chronic AD may cause asthma, food allergies, eye infections, and sleep problems. The cause of AD might be related to bacteria that live on the skin. Resea...

What is the current status of trial NCT03018275?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2017-04-20. Estimated completion is 2019-10-11.

What interventions are being tested in trial NCT03018275?

The interventions under investigation include: Roseomonas mucosa (BIOLOGICAL).

Who is sponsoring clinical trial NCT03018275?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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