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Colloidal Oatmeal · 1 trial · 1 indication
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; ...
Colloidal Oatmeal is a small molecule being studied for use in eczema, specifically to treat dry, itchy skin in babies. It is being developed as a topical cream. The drug is currently in Phase 3 clinical development and remains investigational, meaning it has not yet been approved by the FDA.
Colloidal Oatmeal is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical research to evaluate the safety and usefulness of the cream in treating eczema-related dry, itchy skin in infants.
Colloidal Oatmeal is in Phase 3 clinical development for eczema. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being evaluated for its safety and usefulness in treating dry, itchy skin in babies.
Colloidal Oatmeal has one completed Phase 3 clinical trial registered under NCT02120833. The trial, titled "A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin," enrolled 51 participants with eczema in the United States. The study was randomized, double-blind, and active-controlled.
Colloidal Oatmeal is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for eczema. A Phase 3 trial has been completed to evaluate its safety and usefulness in treating dry, itchy skin in babies, but the drug has not yet received regulatory approval.