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Atopic DermatitisPhase 1/2NCT03018275

Beginning Assessment of Cutaneous Treatment Efficacy of Roseomonas in Atopic Dermatitis

A Phase 1/2 study testing Roseomonas mucosa in people with Atopic Dermatitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 99 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Roseomonas mucosa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited States
Study dates
20 Apr 2017to 11 Oct 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Inclusion Criteria for Young Adults and Adults with AD (Part 1)
  • Age 16+ years
  • SCORAD of at least 10
  • Have a clinical diagnosis of AD with active involvement of the antecubital fossa
  • Willing to allow storage of blood for future research
  • No history of other skin disease
Show all 14Show fewer
  • Initiated or attempted standard of care therapy at least 6 months prior to enrollment
  • Must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) when engaging in sexual activities that can result in pregnancy. The effects of CGN live biotherapy on the developing human fetus are unknown. Adequate contraception must be used consistently, beginning before the first dose and lasting for the duration of study participation. Participants of childbearing potential must have a negative pregnancy test result before they receive CGN live biotherapy. During the course of the study, if a participant becomes pregnant or suspects they are pregnant, then they should inform the study staff and their primary care physician immediately.
  • Age 3-16 years
  • SCORAD of at least 10
  • Have a clinical diagnosis of AD with active involvement of the antecubital fossa
  • Willing to allow storage of blood and bacterial swabs for future research
  • Initiated or attempted standard of care therapy at least 6 months prior to enrollment
  • Participants who have begun menstruating must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) when engaging in sexual activities that can result in pregnancy.

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Beginning Assessment of Cutaneous Treatment Efficacy of Roseomonas in Atopic Dermatitis Phase I/II

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.

Read more

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

Read the 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.

Being tested
Roseomonas mucosa
Keywords
Lyophilized Biotherapeutic, Microbiome, Probiotic, Commensal Gram-negative Bacteria, Staphylococcus Aureus, Transepidermal Water Loss, Allergic Diseases
Medical subject headings
Dermatitis, Atopic, Staphylococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Roseomonas mucosaBiological

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

Study groups in NCT03018275
Study groupRoleWhat they receive
1ExperimentalVials of lyophilized R mucosa (10"3, 10"4, or 10"5 CFU)
Receives: Biological: Roseomonas mucosa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A 50% reduction in antecubital-specific SCORing Atopic Dermatitis (SCORAD) with no adverse events related to product use. Frequency of solicited adverse events, unsolicited adverse events, serious adverse events, and death.

    Measured: 4 weeks, 8 weeks, 12 weeks, 16 weeks, 8 months, 12 months, and 16 months

Secondary outcomes (2)

  1. A 30% improvement in the quality of life as measured by the validated Children's Dermatology Life Quality Index (CDLQI)

    Measured: 4 weeks, 8 weeks, 12 weeks, 16 weeks, 8 months, 12 months, and 16 months

  2. A 30% improvement in the quality of life as measured by the validated Family Dermatology Life Quality Index (FDLQI)

    Measured: 4 weeks, 8 weeks, 12 weeks, 16 weeks, 8 months, 12 months, and 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2017 (estimated)
  2. Study start20 Apr 2017
  3. Primary completion11 Oct 2019
  4. Study completion11 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03018275
Sponsor's protocol ID
170033
Other IDs
17-I-0033
Status last verified
Oct 2019
First submitted
11 Jan 2017
Last updated
27 Nov 2019
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Boguniewicz M, Leung DY. Recent insights into atopic dermatitis and implications for management of infectious complications. J Allergy Clin Immunol. 2010 Jan;125(1):4-13; quiz 14-5. doi: 10.1016/j.jaci.2009.11.027.

    PubMed 20109729

  • Myles IA, Williams KW, Reckhow JD, Jammeh ML, Pincus NB, Sastalla I, Saleem D, Stone KD, Datta SK. Transplantation of human skin microbiota in models of atopic dermatitis. JCI Insight. 2016 Jul 7;1(10):e86955. doi: 10.1172/jci.insight.86955.

    PubMed 27478874

  • Bantz SK, Zhu Z, Zheng T. The Atopic March: Progression from Atopic Dermatitis to Allergic Rhinitis and Asthma. J Clin Cell Immunol. 2014 Apr;5(2):202. doi: 10.4172/2155-9899.1000202.

    PubMed 25419479

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Roseomonas mucosa in people with Atopic Dermatitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A 50% reduction in antecubital-specific SCORing Atopic Dermatitis (SCORAD) with no adverse events related to product use. Frequency of solicited adverse events, unsolicited adverse events, serious adverse events, and death. (time frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks, 8 months, 12 months, and 16 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03018275, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.

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