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Activated Oil-Enhanced Oatmeal Formulation for Eczema
N/A
Recruiting
Research Sponsored by GlycosBio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of mild to moderate eczema (grade 3 - 7 on the Rajka-Langeland severity index).
Having a target lesion with an ADSI score of 6-12 and an erythema and pruritus subscore of ³2 (moderate).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
Study Summary
This trial is seeing if adding a modified plant oil to a standard over-the-counter oatmeal formulation for eczema affects the skin microbiome.
Who is the study for?
This trial is for males and females with mild to moderate eczema, experiencing a recent itch flare-up. Participants must be willing to follow the study procedures, stop using other skin products, and women of childbearing age should use birth control. People with HIV, pregnancy, certain cancer histories, allergies to specific medications or recent antibiotic use cannot join.Check my eligibility
What is being tested?
The trial is testing an over-the-counter topical colloidal oatmeal formulation against the same formulation amended with Activated Oil (AO) on patients' skin microbiome. It's a controlled study where participants are randomly assigned to one of these treatments without knowing which one they're getting.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions associated with topical skin treatments such as redness, irritation or itching at the application site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My eczema is mild to moderate, scoring 3 to 7 on a severity scale.
Select...
My skin lesion is moderately red and itchy, scoring 6-12 on the ADSI.
Select...
My eczema is mild to moderate, based on its severity score.
Select...
My skin lesion is moderately red and itchy, scoring 6-12 on the ADSI.
Select...
I can stop using all skin creams and lotions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Atopic Dermatitis Severity Index (ADSI) score
Staphylococcus aureus
Secondary outcome measures
Change in Eczema Area and Severity Index (EASI) score
Change in Shannon Diversity Index between the target lesion site and non-lesion site
Staphylococcus aureus
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ProtocolExperimental Treatment1 Intervention
Standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation with a modified plant oil ("Activated Oil", AO) applied to designated "target lesion sites" and "non-lesion sites" (study sites) twice per day for 14 days, followed by a 7-day regression durability period during when no product is applied.
Group II: ControlActive Control1 Intervention
Standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation amended with deionized water to match the colloidal oatmeal concentration of the Protocol arm applied to designated "target lesion sites" and "non-lesion sites" (study sites) twice per day for 14 days, followed by a 7-day regression durability period during when no product is applied.
Find a Location
Who is running the clinical trial?
GlycosBio, Inc.Lead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Center for Clinical Studies, TexasOTHER
2 Previous Clinical Trials
133 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recently experienced an increase in eczema itchiness.I have not used any antibiotics, whether cream or pills, in the last week.I have not taken a bleach bath in the week before my first clinic visit.I am willing and able to follow the study rules and attend all appointments.I am currently using medications or creams for my eczema or skin condition.You are willing to comply with all study procedures and are available for the duration of the study.My skin lesion is moderately red and itchy, scoring 6-12 on the ADSI.My eczema is mild to moderate, scoring 3 to 7 on a severity scale.I can stop using all skin creams and lotions.I can apply creams or ointments and will follow the study's treatment plan.I have recently experienced an increase in eczema itchiness.I agree to use birth control during and for 30 days after the study.My eczema is mild to moderate, based on its severity score.I have been diagnosed with HIV.I have no surgeries or invasive procedures planned during the study.I haven't had cancer in the study area in the last 5 years.I haven't taken any experimental drugs or skin treatments in the last 30 days.I can apply medication on my skin and will follow the study's treatment plan.My skin lesion is moderately red and itchy, scoring 6-12 on the ADSI.
Research Study Groups:
This trial has the following groups:- Group 1: Protocol
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently seeking volunteers for this clinical trial?
"Clinicaltrials.gov provides evidence that this medical trial is currently in search of participants, having been first posted on June 17th 2022 and last updated a fortnight later."
Answered by AI
What ultimate goals is this experiment intending to realize?
"The main outcome of this 14-day trial is the Atopic dermatitis Severity Index (ADSI) score. Secondary objectives include determining the Difference in Shannon Diversity Index at a target lesion site compared to baseline measurements, Change in Shannon Diversity index between targeted lesions and non-lesions sites, and observing differences in S. aureus relative abundance on non-targeted parts of the body over time when comparing protocol versus control arms."
Answered by AI
What is the maximum capacity for this trial in terms of number of participants?
"Affirmative. Examination of clinicaltrials.gov reveals that this medical trial, inaugurated on June 17th 2022 is currently recruiting participants. 60 volunteers are required from 1 research centre for the duration of the experiment."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Center for Clinical Studies
What portion of applicants met pre-screening criteria?
Met criteria
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