Beginning Assessment of Cutaneous Treatment Efficacy of Roseomonas in Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1/Phase 2

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
    

Detailed description: 
      The underlying pathology of atopic dermatitis (AD) consists of defective skin barrier
      function, susceptibility to Staphylococcus aureus skin infection, and immune imbalance. There
      is currently no cure for AD. Preclinical data in a mouse model of AD suggest that commensal
      Gram-negative bacteria (CGN), such as Roseomonas mucosa, from a healthy source can relieve
      symptoms of AD and have antimicrobial effects. In this study, we will first evaluate the
      safety of R mucosa-based biotherapy in adults with AD (age 18+ years; part 1), and then
      evaluate the safety and activity of R mucosa-based biotherapy in children (ages 3-17 years)
      with AD (parts 2A and 2B). In part 1, participants will receive twice-weekly doses of CGN
      biotherapy for 6 weeks, with dose escalations at 2 and 4 weeks. In part 2, participants will
      receive twice-weekly doses of CGN biotherapy for 4 months, with possible dose escalations at
      4 and 8 weeks (part 2A only). Starting at 12 weeks for both parts 2A and 2B, dosing frequency
      may be increased to every other day. Participants in part 1 will be contacted 30 10 days
      after end of treatment for assessment of safety. Participants in parts 2A and 2B will also be
      followed for up to 1 year after the end of treatment for evaluation of long-term activity and
      safety. This will be the first study to test cutaneous live biotherapeutic products for AD.
      We hypothesize that altering the strains of CGN on the skin of people with AD will improve
      the patient s clinical outcome. We do not expect serious toxicities because R mucosa is
      rarely pathogenic; reported cases of bacteremia have typically been associated with
      percutaneous catheters in immunocompromised patients, who are excluded from this study.
    

Intervention name(s): Roseomonas mucosa
Intervention type(s): Biological
Intervention description(s): R mucosa grown in Hank's balanced salt solution. Bacteria is washed, quantitated spectrophotometrically, suspended in 10%-15% sucrose, and lyophilized.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lyophilized Biotherapeutic, Microbiome, Probiotic; Commensal Gram-negative Bacteria; Staphylococcus Aureus; Transepidermal Water Loss; Allergic Diseases