Human Testing of an Over-the-Counter (OTC) Cream in Children With Eczema

Study Overview
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Brief Summary
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This three week study will be conducted to determine the safety and efficacy of an over-the-counter (OTC) cream in children with mild to moderate atopic dermatitis.

Detailed Description
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The objective of this trial is to evaluate the efficacy and safety of an OTC colloidal oatmeal skin protectant cream in children with mild to moderate AD in comparison to that of EpiCeram®

Official Title
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A Double-Blind, Randomized, Active-Controlled Clinical Trial to Evaluate the Efficacy and Safety of an Over-the-Counter Cream in the Management of Mild to Moderate Atopic Dermatitis in Children

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Colloidal Oatmeal
* Device: Topical Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children ages 6 mo- 18 years Any ethnicity Diagnosed with atopic dermatitis (AD) per Hanifin-Rajka criteria Mild to moderate atopic dermatitis per Rajka-Langeland severity index Willing to use only provided cream and body wash for duration of study Exclusion Criteria: Known sensitivity to investigational products Pregnant or breastfeeding Severe AD per Rajka-Langeland severity index AD requiring class I (super potent) or class II or III (potent) topical steroids Requires greater than 2.0 g inhaled or intranasal corticosteroids Other skin conditions which may interfere with the scoring of AD

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 19306-127<br>Experimental Topical cream applied twice daily (or as needed) | Drug: Colloidal Oatmeal<br>* Topical cream applied twice daily (or as needed)<br>* Other names: Not yet marketed;|
| Other: 19306-137<br>Marketed Topical cream applied twice daily (or as needed) | Device: Topical Cream<br>* Topical cream applied twice daily (or as needed)<br>* Other names: EpiCeram;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eczema Area and Severity Index (EASI) | A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72 | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interim Eczema Area and Severity Index (EASI) | Number of subjects improved at Week 2 compared to Baseline in EASI. Improved is defined as post baseline EASI score smaller than baseline score. | Week 2 | 
| Assessment of Itch | Subject's or caregiver's assessment of itch, on a 10-cm Visual Analogue Scale (VAS), where 0-no itch, 10-worst itch imaginable | through Week 3 | 
| Investigator's Global Atopic Dermatitis Assessment (IGADA) | An assessment of Atopic Dermatitis based on a 4 point scale where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating will be 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe, or 5-very severe. | through Week 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eczema