Beginning Assessment of Cutaneous Treatment Efficacy of Roseomonas in Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT03018275|
Recruitment Status : Recruiting
First Posted : January 12, 2017
Last Update Posted : May 14, 2018
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.
To test the safety and activity of R mucosa for treating AD.
Part 1: People ages 18 and older with AD
Part 2: Children ages 3-17 with AD
Participants will be screened with:
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
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Biological: Roseomonas mucosa||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Beginning Assessment of Cutaneous Treatment Efficacy of Roseomonas in Atopic Dermatitis Phase I/II|
|Study Start Date :||January 11, 2017|
|Estimated Primary Completion Date :||May 30, 2019|
|Estimated Study Completion Date :||May 30, 2019|
Vials of lyophilized R mucosa (10"3, 10"4, or 10"5 CFU)
Biological: Roseomonas mucosa
R mucosa grown in Hank's balanced salt solution. Bacteria is washed, quantitated spectrophotometrically, suspended in 10%-15% sucrose, and lyophilized.
- 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 ]
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018275
|Contact: Ian A Myles, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Ian A Myles, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|