Cardamom and Topical Roseomonas in Atopic Dermatitis (NCT06096857)
A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Trial of Cardamom and Topical Roseomonas in Atopic Dermatitis
๐ฉบ Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: National Institutes of Health Clinical Center โ Bethesda, Maryland
Age range: 2 Years to 100 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- National Institutes of Health Clinical Center โ Bethesda, Maryland
๐ Contact the Study Coordinator
Phone: (301) 605-2896
Email: jodi.blake@nih.gov
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Atopic Dermatitis
- A Study to See How Well Lebrikizumab Works in Adults and Adolescents With Moderate Atopic Dermatitis (Eczema) and High Itch Burden โ Birmingham, Alabama
- ATI-045 Versus Placebo in Patients With Moderate-to-Severe Atopic Dermatitis โ Phoenix, Arizona
- A Study of Barzolvolimab in Patients With Atopic Dermatitis โ Birmingham, Alabama
- Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis โ Chicago, Illinois
- A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis โ Birmingham, Alabama
- A Study Evaluating APG777 in Atopic Dermatitis โ Fountain Valley, California
Explore by condition: All Atopic Dermatitis clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.