Cardamom and Topical Roseomonas in Atopic Dermatitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-100
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
Background:
Atopic dermatitis (AD), also called eczema, is a chronic skin condition. AD can make skin dry and itchy, and sometimes it can lead to serious health problems, such as asthma, food allergies, eye infections, and sleep problems. No cure exists for AD. Researchers know that people with AD have different kinds of harmless bacteria on their skin than do people without AD. They want to see if adding a harmless bacteria (Roseomonas mucosa) to the skin can help people with AD.
Objective:
To test a skin treatment that contains R. mucosa and ground cardamom seeds in people with AD.
Eligibility:
People aged 2 years and older with AD.
Design:
All study visits will be remote. Participants will have 5 visits over about 7 months.
Participants will be screened. Researchers will review their AD and medical history.
Participants will receive a study product in the mail. The product comes as a powder in single-use packets. Participants will be shown how to mix the powder with water in a single-use spray vial. They will spray the solution onto their skin 2 to 3 times per week for 14 weeks.
Half of participants will receive the study powder. Half will receive a placebo; the placebo looks just like the study powder but contains no bacteria. They will not know which one they have.
During 3 study visits, participants will take a skin swab. They will receive supplies in the mail to rub a cotton swab on their skin and mail it back to the researchers.
Participants may opt to have pictures taken of their AD.
Participants will fill out 4 online questionnaires.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged >=2 years
Have a documented primary care provider near residence
Fluency in English (applicable to participant or caregiver who will be answering questionnaires)
Clinical diagnosis of AD, as defined by Hanifin and Rajka criteria, that has been present for >=3 months before the screening visit
Disqualifiers
Immunosuppressive or immunomodulating systemic drugs such as systemic corticosteroids, azathioprine, methotrexate, cyclosporine
Phototherapy or photochemotherapy for AD
Topical steroids or topical calcineurin inhibitors
Janus kinase (JAK) inhibitors (oral or topical)
Trial design
Design model
Parallel
Treatments tested in this trial
Roseomonas mucosa (RSM2015) and Cardamom seeds
DrugFreeze dried packet to be reconstituted in water
Placebo (sucrose)
DrugFreeze dried packet to be reconstituted in water
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: ActiveActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
To determine if R mucosa combined with ground cardamom seeds can improve symptoms of AD in patients aged 2 and older, 14 weeks after treatment discontinuation.
Proportion of participants achieving a 90% improvement in EASI90 (a measure of eczema rash) from baseline (week 0) to study completion (week 28).
Time frame
From Baseline (week 0 to week 28)Secondary outcomes
1
To determine if R mucosa combined with ground cardamom seeds can improve symptoms of AD in patients aged 2 and older, during active treatment as well as 7 weeks after treatment discontinuation.
1\. Proportion of AEs. 2. Proportion of participants using topical steroids over the course of the study.3. Change and percent change in IGA (a measure of eczema rash) from baseline (week 0) to: treatment completion (week 14), mid-washout (week 21) and study completion (week 28).4. Change and percent change in NRS (subjective measure of itch) from baseline (week 0) to: treatment completion (week 14), mid-washout (week 21), and study completion (week 28).5. Change and percent change in SCORAD (a combined metric of eczema itch, rash, QoL) from baseline (week 0) to: treatment completion (week 14), mid-washout (week 21), and study completion (week 28).6. Change and percent change in QOL measures, POEM, from baseline (week 0) to: treatment completion (week 14), mid-washout (week 21), and study completion (week 28).
Time frame
Week 7 to week 28Sponsors and contacts
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Source ClinicalTrials.gov