RECRUITING

Cardamom and Topical Roseomonas in Atopic Dermatitis

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Conditions

Atopic DermatitisEczemaRoseomonasCardamomItchRash

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Trial of Cardamom and Topical Roseomonas in Atopic Dermatitis

Quick Facts

Study Start:2024-10-09
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06096857

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Aged \>=2 years
  2. 2. Have a documented primary care provider near residence
  3. 3. Fluency in English (applicable to participant or caregiver who will be answering questionnaires)
  4. 4. Clinical diagnosis of AD, as defined by Hanifin and Rajka criteria, that has been present for \>=3 months before the screening visit
  5. * Major Criteria: Must have \>=3 basic features:
  6. * Pruritus
  7. * Typical morphology and distribution (flexural lichenification in adults, facial and extensor eruptions in infants and children)
  8. * Chronic or chronically relapsing dermatitis
  9. * Personal or family history of atopy (asthma, allergic rhinitis, AD)
  10. * Minor Criteria: Must have \>=3 minor features:
  11. * Xerosis
  12. * Ichthyosis/palmar hyperlinearity, keratosis pilaris
  13. * Immediate (type 1) skin-test reactivity
  14. * Raised serum IgE
  15. * Early age of onset
  16. * Tendency toward cutaneous infections (especially Staphylococcus aureus and herpes simplex), impaired cell-mediated immunity
  17. * Tendency toward non-specific hand or foot dermatitis
  18. * Nipple eczema
  19. * Cheilitis
  20. * Recurrent conjunctivitis
  21. * Dennie-Morgan infraorbital fold
  22. * Keratoconus
  23. * Anterior subcapsular cataracts
  24. * Orbital darkening
  25. * Facial pallor, facial erythema
  26. * Pityriasis alba
  27. * Anterior neck folds
  28. * Itch when sweating
  29. * Intolerance to wool and lipid solvents
  30. * Perifollicular accentuation
  31. * Food intolerance
  32. * Course influenced by environmental or emotional factors
  33. * White dermographism, delayed blanch
  34. 5. EASI \>5 and/or an IGA \>=1 at time of enrollment.
  35. 6. 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.
  36. 7. Participants and parents/legal guardians (for minor participants) are willing and able to comply with all study visits and/or study-related procedures.
  37. 8. Participants/parents/guardians must have the ability to provide informed consent/assent as applicable.
  38. 9. Willingness to perform visits virtually.
  1. 1. Previous treatment of AD:
  2. * Within 4 weeks prior to the baseline visit with any of the following:
  3. * Immunosuppressive or immunomodulating systemic drugs such as systemic corticosteroids, azathioprine, methotrexate, cyclosporine
  4. * Phototherapy or photochemotherapy for AD
  5. * Within 12 weeks prior to the baseline visit with any of the following having been newly initiated:
  6. * Topical steroids or topical calcineurin inhibitors
  7. * Janus kinase (JAK) inhibitors (oral or topical)
  8. * Dupilumab or any other biologic agent
  9. * Topical PDE4 inhibitor
  10. * Emollients containing ceramides, hyaluronic acid, urea or filaggrin degradation products.
  11. * Bleach baths
  12. 2. Active infection (chronic or acute) requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the baseline visit.
  13. 3. Superficial skin infection requiring topical treatment within 1 week of baseline visit.
  14. 4. Known or suspected history of immunosuppression or immunodeficiency.
  15. 5. Existence of indwelling central line.
  16. 6. Co-habitation with someone that has a known or suspected history of immunosuppression or immunodeficiency or has a central line.
  17. 7. Any clinically significant laboratory, history, or exam findings that, in the investigator s opinion, would suggest an increased risk to the participant.
  18. 8. Self-reported pregnancy or breastfeeding.
  19. 9. 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 will not be excluded.

Contacts and Locations

Study Contact

Ashleigh A Sun
CONTACT
(301) 605-2896
sunaa@niaid.nih.gov
Ian A Myles, M.D.
CONTACT
(301) 451-8420
mylesi@niaid.nih.gov

Principal Investigator

Ian A Myles, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

  • Ian A Myles, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-09
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2024-10-09
Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

  • Eczema
  • Atopic Dermatitis
  • Roseomonas
  • Cardamom
  • Itch
  • Rash

Additional Relevant MeSH Terms

  • Atopic Dermatitis
  • Eczema