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New treatment option for Atopic Dermatitis
Official title Cardamom and Topical Roseomonas in Atopic Dermatitis
ClinicalTrials.gov ID: NCT06096857
What this study is testing
What is Roseomonas mucosa (RSM2015) and Cardamom seeds?
Roseomonas mucosa (RSM2015) and Cardamom seeds is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for atopic dermatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 100
You may be able to join if
- To be eligible to participate in this study, an individual must meet all of the following 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
You likely can't join if
- Previous treatment of AD:
- Within 4 weeks prior to the baseline visit with any of the following:
- Immunosuppressive or immunomodulating systemic drugs such as systemic corticosteroids, azathioprine, methotrexate, cyclosporine
- Phototherapy or photochemotherapy for AD
- Within 12 weeks prior to the baseline visit with any of the following having been newly initiated:
- Topical steroids or topical calcineurin inhibitors
See the full eligibility criteria
- To be eligible to participate in this study, an individual must meet all of the following 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
- Major Criteria: Must have \>=3 basic features:
- Pruritus
- Typical morphology and distribution (flexural lichenification in adults, facial and extensor eruptions in infants and children)
- Chronic or chronically relapsing dermatitis
- Personal or family history of atopy (asthma, allergic rhinitis, AD)
- Minor Criteria: Must have \>=3 minor features:
- Xerosis
- Ichthyosis/palmar hyperlinearity, keratosis pilaris
- Immediate (type 1) skin-test reactivity
- Raised serum IgE
- Early age of onset
- Tendency toward cutaneous infections (especially Staphylococcus aureus and herpes simplex), impaired cell-mediated immunity
- Tendency toward non-specific hand or foot dermatitis
- Nipple eczema
- Cheilitis
- Recurrent conjunctivitis
- Dennie-Morgan infraorbital fold
- Keratoconus
- Anterior subcapsular cataracts
- Orbital darkening
- Facial pallor, facial erythema
- Pityriasis alba
- Anterior neck folds
- Itch when sweating
- Intolerance to wool and lipid solvents
- Perifollicular accentuation
- Food intolerance
- Course influenced by environmental or emotional factors
- White dermographism, delayed blanch
- 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...
- 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.
- Willingness to perform visits virtually.
- Previous treatment of AD:
- Within 4 weeks prior to the baseline visit with any of the following:
- Immunosuppressive or immunomodulating systemic drugs such as systemic corticosteroids, azathioprine, methotrexate, cyclosporine
- Phototherapy or photochemotherapy for AD
- Within 12 weeks prior to the baseline visit with any of the following having been newly initiated:
- Topical steroids or topical calcineurin inhibitors
- Janus kinase (JAK) inhibitors (oral or topical)
- Dupilumab or any other biologic agent
- Topical PDE4 inhibitor
- Emollients containing ceramides, hyaluronic acid, urea or filaggrin degradation products.
- Bleach baths
- 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.
- Self-reported pregnancy or breastfeeding.
- Menstruating females who have not menstruated within 6 weeks prior to screening. Participants who have an intrauterine device or implanted long-term contraceptive agent that prevents them from menstruating regularly...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.