A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Trial of Cardamom and Topical Roseomonas in Atopic Dermatitis
National Institute of Allergy and Infectious Diseases (NIAID)
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.
Description
Study Description: This is a double-blind, randomized, phase 2b clinical trial for a topical formulation of a live biotherapeutic containing Roseomonas mucosa combined with ground cardamom seeds in a sucrose solution for patients with atopic dermatitis (AD). Participants will reconstitute the dried product in water and apply topically 2 or 3 times per week for 14 weeks. After 14 weeks, all interventions will cease, and participants will be followed for an additional 14 weeks to assess how long treatment effects last. During the course of study, we will assess disease severity (eg, itch, rash,…
Eligibility
- Age range
- 2–100 years
- Sex
- All
- Healthy volunteers
- No
* INCLUSION CRITERIA: To be eligible to participate in this study, an individual must meet all of the following criteria: 1. Aged \>=2 years 2. Have a documented primary care provider near residence 3. Fluency in English (applicable to participant or caregiver who will be answering questionnaires) 4. 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 ex…
Interventions
- DrugRoseomonas mucosa (RSM2015) and Cardamom seeds
Freeze dried packet to be reconstituted in water
- DrugPlacebo (sucrose)
Freeze dried packet to be reconstituted in water
Location
- National Institutes of Health Clinical CenterBethesda, Maryland