Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06096857
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-10-21
Brief Title:
Cardamom and Topical Roseomonas in Atopic Dermatitis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase 2b Double-Blind Randomized Placebo-Controlled Trial of Cardamom and Topical Roseomonas in Atopic Dermatitis
Status:
RECRUITING
Status Verified Date:
2024-10-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 baselineweek 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 baselineweek 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 001677-I | None | None | None |