Cardamom and Topical Roseomonas in Atopic Dermatitis
- Conditions
- Atopic DermatitisEczema
- Interventions
- Drug: Placebo (sucrose)Drug: Roseomonas mucosa (RSM2015) and Cardamom seeds
- Registration Number
- NCT06096857
- Brief 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.
- Detailed 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, and quality of life \[QOL\]) using a variety of AD assessments, ease of compliance with treatment, and changes in the microbiome profile of the skin. We hypothesize that topical treatment with Roseomonas mucosa, combined with ground cardamom seeds, will provide significantly more alleviation in AD symptoms than placebo, and that these effects will last beyond active treatment (due to the ability of the bacteria to colonize the patients' skin).
Primary Objective:
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 Objective:
1. To determine if R mucosa combined with ground cardamom seeds can improve the Investigator s Global Assessment (IGA) in patients aged 2 and older, during active treatment as well as 7 weeks after treatment discontinuation, and at study completion.
2. To determine if R mucosa combined with ground cardamom seeds can improve the Numerical Rating Scale (NRS; both for average and worse severity over the 2-3 weeks prior to assessment) in patients aged 2 and older, during active treatment as well as 7 weeks after treatment discontinuation, and at study completion.
3. To determine if R mucosa combined with ground cardamom seeds can improve the SCORing Atopic Dermatitis (SCORAD) in patients aged 2 and older, during active treatment as well as 7 weeks after treatment discontinuation, and at study completion.
4. To determine if R mucosa combined with ground cardamom seeds can improve the Patient-Oriented Eczema Measure (POEM) in patients aged 2 and older, during active treatment as well as 7 weeks after treatment discontinuation, and at study completion.
5. To determine if effects of R mucosa combined with ground cardamom seeds on the symptoms of AD differ by levels of pollution near home of residence.
6. To determine if use of R mucosa permits less use of topical steroid treatments.
7. To determine the safety of R mucosa use.
Exploratory Objectives:
1. To determine if patients and caregivers using topical R mucosa understand the instructions and precautions for use.
2. To determine if topical R mucosa with cardamom seeds alters the skin microbiome profile during and after treatment.
3. To determine if topical R mucosa colonizes the skin of patients during use.
Primary Endpoint:
Proportion of participants achieving a 90% improvement in Eczema Area and Severity Index (EASI90; a measure of eczema rash) from baseline(week 0) to study completion (week 28).
Secondary Endpoints:
1. Proportion of adverse events (AEs).
2. Mean number of average weekly topical steroid use over the study follow up.
3. Change and percent change in IGA (a measure of eczema rash) from baseline (week 0) to: treatment completion (week 14), mid-follow-up (week 21), and study completion (week 28).
4. Change and percent change in NRS (subjective measure of itch) from baseline (week 0) to: treatment completion (week 14), mid-follow-up (week 21), and study completion (week 28).
5. Change and percent change in SCORAD (a combined metric of eczema itch, rash, QOL) from baseline (week 0) to: treatment completion (week 14), mid-follow-up (week 21), and study completion (week 28).
6. Change and percent change in QOL measures, POEM, from baseline (week 0) to: treatment completion (week 14), mid-follow-up (week 21), and study completion (week 28).
7. Proportion of participants achieving a 90% improvement in EASI90 (a measure of eczema rash) from baseline (week 0) to study completion (week 28) in the high-pollution areas and low-pollution areas.
Exploratory Endpoints:
1. Accuracy of identifying correct answers to questions about product applications and precautions.
2. Qualitative input regarding ease of use of product.
3. Presence of treatment strain of R mucosa as assessed by genetic detection (using polymerase chain reaction \[PCR\] primer).
4. Change in skin microbiome profile during and after treatment.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo (sucrose) Sucrose Active Roseomonas mucosa (RSM2015) and Cardamom seeds Roseomonas and Cardamom seeds
- Primary Outcome Measures
Name Time Method 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. From Baseline (week 0 to week 28) Proportion of participants achieving a 90% improvement in EASI90 (a measure of eczema rash) from baseline (week 0) to study completion (week 28).
- Secondary Outcome Measures
Name Time Method 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. Week 7 to week 28 1. Proportion of AEs. 2. Proportion of participants using topical steroids over the course of the study.3. Change and percent change in IGA (a measure of eczema rash) from baseline (week 0) to: treatment completion (week 14), mid-washout (week 21) and study completion (week 28).4. Change and percent change in NRS (subjective measure of itch) from baseline (week 0) to: treatment completion (week 14), mid-washout (week 21), and study completion (week 28).5. Change and percent change in SCORAD (a combined metric of eczema itch, rash, QoL) from baseline (week 0) to: treatment completion (week 14), mid-washout (week 21), and study completion (week 28).6. Change and percent change in QOL measures, POEM, from baseline (week 0) to: treatment completion (week 14), mid-washout (week 21), and study completion (week 28).
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States