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Activated Oil-Enhanced Oatmeal Formulation for Eczema
N/A
Waitlist Available
Research Sponsored by GlycosBio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Provision of signed and dated informed consent form
Generally good health based on reported history
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Atopic Dermatitis Severity Index (ADSI) score
Staphylococcus aureus
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
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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 have recently experienced an increase in eczema itchiness.I can apply creams or ointments and will follow the study's treatment plan.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.
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