Topical Bacteria + Cardamom for Eczema

Phase 2

Recruiting

Led By Ian A Myles, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

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.

Must not have

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

Active infection (chronic or acute) requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the baseline visit.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 7 to week 28

Summary

This trial tests whether a topical formulation of live bacteria and cardamom seeds can improve symptoms of atopic dermatitis and last beyond active treatment.

Who is the study for?

This trial is for people aged 2 years and older with atopic dermatitis (AD), also known as eczema. Participants must be willing to do virtual visits, speak English, have a primary care provider nearby, and use contraception if of childbearing potential. They should not have used certain AD treatments recently or have infections needing systemic treatment.

What is being tested?

The study tests a skin treatment combining Roseomonas mucosa bacteria and ground cardamom seeds against a placebo. Over about 7 months, participants will apply the mixture or placebo to their skin several times per week and complete online questionnaires.

What are the potential side effects?

Potential side effects are not detailed in the provided information but could include typical reactions to topical treatments such as skin irritation, redness, or itching. Since this is an investigational product, unexpected side effects may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have at least 3 symptoms of eczema, including itching, skin rash, and a history of allergies.

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I agree to use birth control during and 30 days after treatment if I can have children.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't used certain immune-affecting drugs or light therapy for my skin condition in the last 4 weeks.

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I have not taken antibiotics, antivirals, or antifungals for an infection in the last 2 weeks.

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I have a history of weak immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 7 to week 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 7 to week 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 7 to week 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

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.