Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02120833 | A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin | PHASE3 | COMPLETED | 51 | — | — | Mar 1, 2014 | Nov 1, 2014 | Jan 13, 2017 | 2 | United States |
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 calculation ranging from 0-72.
The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is 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 is categorized as clear, almost clear, mild, moderate, severe, or very severe.
| Arm | Type | Description |
|---|---|---|
| EPI | ACTIVE_COMPARATOR | - |
| NEE | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| EpiCeram® Skin Barrier Emulsion | DEVICE | Device (including sham) Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin as directed. |
| Colloidal Oatmeal Cream | DRUG | Drug (including placebo) Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin as directed. |
Inclusion Criteria 1. Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment; 2. Caregiver is able and willing to provide written informed consent for the participant to participate in the trial; ...