To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the safety of the investigational study product and see how well it works to relieve signs and symptoms of children with mild to moderate Atopic Dermatitis (AD), also known as eczema, in comparison to that of a similar marketed product. This study was conducted to assess the safety of the investigational new study product and how well it works to treat AD in children, by making AD visually better, and reducing the amount of itch.

Detailed Description
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This was a multi-center, double-blind, randomized, active-controlled trial in children 2 to 12 years of age with mild to moderate AD. A sufficient number of subjects were screened to ensure that approximately 80 subjects were randomized, to yield 70 completed subjects. Subjects were randomized to one of the two treatment groups: the J&J Device or Atopiclair®. All subjects were to return to the clinical site for clinical assessments at baseline (Day 1) and at Days 3, 8, 15, 22, 29 and 43 after initial investigational product application. The investigational products were used topically during the duration of the study.

Official Title
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A Double-Blind, Randomized, Active-Controlled Clinical Trial To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Device: F# 11054-010
* Device: F# 10495-053


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-menarchal female subjects must have a negative urine pregnancy test Willing to provide written informed consent/assent Diagnosed as having mild to moderate Atopic Dermatitis (AD) Willing to stop all moisturizers and/or other skin barrier cream or emulsion treatments for the AD condition during the test period and replace with the investigational product assigned in this trial Willing to replace their body wash and/or soaps with the one provided in this trial Exclusion Criteria: Severe AD as determined by the Rajka-Langeland Severity Index AD requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids. If the subject requires any of these medications as rescue therapy during the study, the subject will be discontinued from the trial History of allergy or hypersensitivity to the ingredients of the test devices, nuts or nut oil Cutaneous or systemic viral (including HIV or AIDS), mycotic or bacterial disease requiring a topical or systemic therapy Diabetes mellitus that cannot be controlled by diet alone (i.e., requires systemic medications for control)

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 11054-010<br>F# 11054-010 Investigational Device | Device: F# 11054-010<br>* Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of study. Massage gently into skin.<br>* Other names: Investigational Device;|
| Active Comparator: 10495-053<br>F# 10495-053 Atopiclair | Device: F# 10495-053<br>* Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of study. Massage gently into skin.<br>* Other names: Atopiclair® Skin and Wound Emulsion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline | The surface and severity of eczema is measured using the 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 possible calculation ranging from 0 (none) - 72 (severe). | Baseline to Day 43 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eczema Area and Severity Index (EASI) on Day 15 - Change From Baseline | The surface and severity of eczema is measured using the 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 possible calculation ranging from 0 (none) - 72 (severe). | Baseline to Day 15 | 
| Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 43 - Change From Baseline | The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA), with possible values of clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). | Baseline to Day 43 | 
| Itch Score on Day 43 - Change From Baseline | The subject's and/or caregiver's assessment of itch was measured on a 10-cm visual analog scale (VAS) in which 0 cm represented no itch and 10 cm represented worst itch imaginable. | Baseline to Day 43 | 

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