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Moisturizer
Natural Oil-Based Moisturizer for Eczema
N/A
Recruiting
Research Sponsored by Integrative Skin Science and Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis of active atopic dermatitis
vIGA-AD (validated Investigator Global Assessment-Atopic Dermatitis) score of 'mild' (2) or 'moderate' (3) at Baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial will compare coconut & sunflower seed oil and oatmeal to see how they affect skin conditions in children aged 2-17.
Who is the study for?
This trial is for boys and girls aged 2-17 with active atopic dermatitis, as shown by certain scores on the EASI and vIGA-AD scales. It's not for those allergic to ingredients in the moisturizers being tested, have only hand/foot eczema, are pregnant, have a skin infection or need systemic therapy.Check my eligibility
What is being tested?
The study tests moisturizers made from coconut oil and sunflower seed oil derived isosorbide disesters plus colloidal oatmeal against a control moisturizer to see which helps pediatric atopic dermatitis more effectively.See study design
What are the potential side effects?
Potential side effects may include skin irritation or allergic reactions due to sensitivity to any of the components in the moisturizers such as coconut oil, sunflower seed oil or other ingredients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with active atopic dermatitis.
Select...
My eczema is rated as mild or moderate.
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I am between 2 and 17 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Eczema Area and Severity Index (EASI)
Itch
Shift in the Skin Microbiome
+3 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Experimental Topical ProductActive Control1 Intervention
Topical moisturizer With Colloidal Oatmeal and Isosorbide Diesters + Topical Steroids
Group II: Control Topical ProductPlacebo Group1 Intervention
Topical moisturizer With Colloidal Oatmeal WITHOUT Isosorbide Diesters + Topical Steroids
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Who is running the clinical trial?
Integrative Skin Science and ResearchLead Sponsor
31 Previous Clinical Trials
2,694 Total Patients Enrolled
Sytheon Ltd.Industry Sponsor
6 Previous Clinical Trials
230 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with active atopic dermatitis.My eczema is rated as mild or moderate.I have been diagnosed with Scabies.I haven't used topical calcineurin inhibitors or crisaborole on certain areas for two weeks, or I'm unwilling to stop using them for a washout period.You are allergic to isosorbide diesters, coconut oil, or sunflower seed oil.I only have eczema on my hands and/or feet, nowhere else.I currently have a skin infection.Your eczema severity score is 5 or higher at the beginning of the study.I am currently on or need certain medications like cyclosporine, steroids, methotrexate, or dupilumab.I am between 2 and 17 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Topical Product
- Group 2: Control Topical Product
Awards:
This trial has 0 awards, including: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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