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Colloidal Oatmeal

Phase 3

Eczema | Small molecule | Dermatology |Johnson & Johnson|Trials Updated: Jan 13, 2017

Colloidal Oatmeal development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Mar 2011

Colloidal Oatmeal target and mechanism

ModalitySmall molecule

Also known as Colloidal Oatmeal Cream

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment51

FDA Designations

No designations recorded

Colloidal Oatmeal clinical trials

Colloidal Oatmeal · 1 trial · 1 indication

Phase 3 1
NCT02120833A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy SkinEczema
COMPLETED51 Analytics
PHASE3COMPLETED
A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin
EczemaUnlock trial analytics

Study Endpoints

Primary Endpoints

Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline
Baseline to Day 3

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.

Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline
Baseline to Day 3

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.

Secondary Endpoints

Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline
Baseline to Day 1
Eczema Area and Severity Index (EASI) on Day 2 - Change From Baseline
Baseline to Day 2
Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline
Baseline to Day 7
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EPIACTIVE_COMPARATOR -
NEEEXPERIMENTAL -

Interventions

NameTypeDescription
EpiCeram® Skin Barrier EmulsionDEVICEDevice (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 CreamDRUGDrug (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.
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Eligibility Criteria

Age Range2 Months to 35 Months
SexALL
Healthy VolunteersNo
Study Sites2

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; ...

Countries:United States
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Frequently asked questions about Colloidal Oatmeal

What is Colloidal Oatmeal used for?

Colloidal Oatmeal is used for eczema, a skin condition involving dry, itchy skin. It is being developed as a dermatology treatment by Johnson & Johnson, which trades under the ticker JNJ. The product is also known as Colloidal Oatmeal Cream and has been studied in a Phase 3 trial in babies with dry itchy skin.

Who makes Colloidal Oatmeal?

Johnson & Johnson, which trades under the ticker JNJ, is the developer of Colloidal Oatmeal. The company is studying the product as a dermatological treatment for eczema. It is also referred to as Colloidal Oatmeal Cream.

What phase is Colloidal Oatmeal in?

Colloidal Oatmeal is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The completed study was a randomized, double-blind, active-controlled trial that enrolled 51 participants with eczema in the United States.

What clinical trials is Colloidal Oatmeal in?

Colloidal Oatmeal has been studied in the Phase 3 trial NCT02120833, titled A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin. The trial enrolled 51 participants with eczema in the United States, included males and females from 2 months of age, and has been completed.

Is Colloidal Oatmeal the same as Colloidal Oatmeal Cream?

Yes, Colloidal Oatmeal Cream is another name for Colloidal Oatmeal. Both names refer to the same Johnson & Johnson product being developed for eczema. The Phase 3 trial NCT02120833 studied a cream used on babies with dry itchy skin.