- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03018275
Beginning Assessment of Cutaneous Treatment Efficacy of Roseomonas in Atopic Dermatitis
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.
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
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
- 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.
Inclusion Criteria for Children with AD (Part 2)
- 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.
EXCLUSION CRITERIA:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Vials of lyophilized R mucosa (10"3, 10"4, or 10"5 CFU)
|
R mucosa grown in Hank's balanced salt solution.
Bacteria is washed, quantitated spectrophotometrically, suspended in 10%-15% sucrose, and lyophilized.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
4 weeks, 8 weeks, 12 weeks, 16 weeks, 8 months, 12 months, and 16 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
A 30% improvement in the quality of life as measured by the validated Children's Dermatology Life Quality Index (CDLQI)
Time Frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks, 8 months, 12 months, and 16 months
|
4 weeks, 8 weeks, 12 weeks, 16 weeks, 8 months, 12 months, and 16 months
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A 30% improvement in the quality of life as measured by the validated Family Dermatology Life Quality Index (FDLQI)
Time Frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks, 8 months, 12 months, and 16 months
|
4 weeks, 8 weeks, 12 weeks, 16 weeks, 8 months, 12 months, and 16 months
|
Collaborators and Investigators
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 170033
- 17-I-0033
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atopic Dermatitis
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-
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SanofiCompletedAtopic Dermatitis | Dermatitis AtopicChina
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National Institute of Allergy and Infectious Diseases...Atopic Dermatitis Research NetworkCompletedAtopic Dermatitis (AD) | Non-atopic Healthy ControlsUnited States
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