Beginning Assessment of Cutaneous Treatment Efficacy of Roseomonas in Atopic Dermatitis

Completed · Phase 1/Phase 2

Conditions studied: Atopic Dermatitis

In brief

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

Key facts

Study ID

NCT03018275

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

31

Starts

2017-04-20

Expected to finish

2019-10-11

Last updated by the study team

2019-11-27

Who can join

Age: 3 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Presence of an indwelling venous or arterial catheter
• Individuals living with anyone with a diagnosed immunodeficiency, cardiac valvular disease, and/of indwelling catheter
• Precence of allergies to aimkacin, ciprofloxacin, gentamicin, levofloxacin, and tobramycin (which would preclude treatment of any unexpected infection)
• History of cardiac valvular disease
• Any history of grade 2 or higher neutropenia or leukopenia
• Clinical suspicion of immunodeficiency, liver disorder, kidney disorder, and/or HIV
• Pregnant or breastfeeding
• Any history of anti-TNF treatment
• Inability to demonstrate proper bacteria administration procedure despite coaching and training
• Use of fluoroquinolone or aminoglycoside antibiotics within 2 weeks of enrollment
• Any condition that, in the opinion of the investigator, contraindicates participation in this Study
• Co-enrollment guidelines: Co-enrollment in other trials is restricted, other than enrollment on observational studies or those evaluating the use of a licensed medication. Study staff should be notified of co-enrollment as it may require the approval of the investigator.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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