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.
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.
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Contact Information
Office/Contact: NIH Clinical Center Office of Patient Recruitment (OPR)
Phone: 800-411-1222
TTY: TTY dial 711
Email: ccopr@nih.gov