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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Initial worst itch numerical rating scale (WI-NRS) for itch greater than 4
Age greater than 12 years
Must not have
Use of any other non-emollient therapy within 28 days of entering the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study the use of a natural, over-the-counter product to help people with atopic dermatitis, a skin condition that causes itching.
Who is the study for?
This trial is for individuals over 12 years old who have had atopic dermatitis (eczema) for more than two years and are experiencing significant itching. Participants must not have used non-emollient therapies or corticosteroids in the past 28 days, and cannot be pregnant or nursing.
What is being tested?
The study is testing the effectiveness of a natural product, 3% kanuka oil, compared to a standard treatment, 1% hydrocortisone cream, in reducing itchiness associated with atopic dermatitis.
What are the potential side effects?
Potential side effects may include skin irritation or allergic reactions from kanuka oil. Hydrocortisone cream can cause skin thinning, discoloration, or worsening of symptoms if overused.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My worst itch score is more than 4.
Select...
I am older than 12 years.
Select...
I have been diagnosed with atopic dermatitis for over 2 years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't used any non-moisturizing treatments in the last 28 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
ISGA
WI-NRS
Awards & 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: 3% Kanuka Oil CreamExperimental Treatment1 Intervention
3% kanuka oil cream will be applied topically to the affected area twice a day for 28 days
Group II: 1% Hydrocortisone CreamActive Control1 Intervention
1% Hydrocortisone Cream will be applied topically to the affected area twice a day for 28 days
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Who is running the clinical trial?
Nexgen Dermatologics, Inc.Lead Sponsor
2 Previous Clinical Trials
135 Total Patients Enrolled
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