Cardamom and Topical Roseomonas in Atopic Dermatitis (NCT06096857) | Clinical Trial Compass
RecruitingPhase 2
Cardamom and Topical Roseomonas in Atopic Dermatitis
United States120 participantsStarted 2024-10-09
Plain-language summary
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.
Who can participate
Age range
2 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. EASI \>5 and/or an IGA \>=1 at time of enrollment.
. Sexually active participants of childbearing potential must agree to use adequate methods of contraception from the screening visit continuously until 30 days after stopping treatment with the investigational product. Childbearing potential is defined for children as participants who have begun menstruating and for adults as participants who are not surgically sterile (hysterectomy and/or tubal ligation) or menopausal (age \>=45 years plus no menses for 12 consecutive months without an alternative medical cause). Adequate contraception methods include: a barrier method (eg, condom use), oral contraceptive pill, hormonal patch or ring, hormonal injection, parenteral hormonal implant, or an intrauterine device.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
Timeframe: From Baseline (week 0 to week 28)
Trial details
NCT IDNCT06096857
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Participants and parents/legal guardians (for minor participants) are willing and able to comply with all study visits and/or study-related procedures.
. Participants/parents/guardians must have the ability to provide informed consent/assent as applicable.
Exclusion criteria
. Previous treatment of AD:
. Active infection (chronic or acute) requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the baseline visit.
. Superficial skin infection requiring topical treatment within 1 week of baseline visit.
. Known or suspected history of immunosuppression or immunodeficiency.
. Existence of indwelling central line.
. Co-habitation with someone that has a known or suspected history of immunosuppression or immunodeficiency or has a central line.
. Any clinically significant laboratory, history, or exam findings that, in the investigator's opinion, would suggest an increased risk to the participant.