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Beginning Assessment of Cutaneous Treatment Efficacy of Roseomonas in Atopic Dermatitis

NCT03018275 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-11-27

No results posted yet for this 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

Conditions

Interventions

BIOLOGICAL

Roseomonas mucosa

R mucosa grown in Hank's balanced salt solution. Bacteria is washed, quantitated spectrophotometrically, suspended in 10%-15% sucrose, and lyophilized.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Ian A Myles, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2019-10-11
Completion
2019-10-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03018275 on ClinicalTrials.gov