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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
Must not have
Subjects with a diagnosis of Scabies
Individuals who have solely hand and/or foot eczema without evidence of eczema anywhere else on their body
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks

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.
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.
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 below
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I have been diagnosed with active atopic dermatitis.
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My eczema is rated as mild or moderate.
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I am between 2 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with Scabies.
Select...
I only have eczema on my hands and/or feet, nowhere else.
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I currently have a skin infection.
Select...
I am currently on or need certain medications like cyclosporine, steroids, methotrexate, or dupilumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Eczema Area and Severity Index (EASI)
Itch
Shift in the Skin Microbiome
+3 more

Trial 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

Find a Location

Who is running the clinical trial?

Integrative Skin Science and ResearchLead Sponsor
32 Previous Clinical Trials
1,934 Total Patients Enrolled
Sytheon Ltd.Industry Sponsor
6 Previous Clinical Trials
230 Total Patients Enrolled

Media Library

Control Moisturizer (Moisturizer) Clinical Trial Eligibility Overview. Trial Name: NCT05688735 — N/A
Atopic Dermatitis Research Study Groups: Experimental Topical Product, Control Topical Product
Atopic Dermatitis Clinical Trial 2023: Control Moisturizer Highlights & Side Effects. Trial Name: NCT05688735 — N/A
Control Moisturizer (Moisturizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05688735 — N/A
~15 spots leftby Nov 2025
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