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Experimental Product 1% Colloidal Oatmeal Balm

Phase 2

Atopic Dermatitis | Small molecule | Dermatology |Johnson & Johnson|Last Updated: Mar 6, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment53

FDA Designations

No designations recorded

Clinical trial landscape

Experimental Product 1% Colloidal Oatmeal Balm · 1 trial · 1 indication

Phase 2 1
NCT02691507Trial to Determine the Therapeutic Benefit of an OTC Cream on Dry, Itchy Skin of Adults and Children With EczemaAtopic Dermatitis
COMPLETED53 Analytics
PHASE2COMPLETED
Trial to Determine the Therapeutic Benefit of an OTC Cream on Dry, Itchy Skin of Adults and Children With Eczema
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in the Itch Assessment Score Immediately Following Treatment
Baseline to immediately following treatment

The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

Change From Baseline in the Itch Assessment Score 1 Hour After Treatment
Baseline to one hour after treatment

The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

Change From Baseline in the Itch Assessment Score 2 Hours After Treatment
Baseline to two hours after treatment

The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

Change From Baseline in the Itch Assessment Score 3 Hours After Treatment
Baseline to three hours after treatment

The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

Change From Baseline in the Itch Assessment Score 4 Hours After Treatment
Baseline to four hours after treatment

The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

Change From Baseline in the Itch Assessment Score 5 Hours After Treatment
Baseline to five hours after treatment

The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

Change From Baseline in the Itch Assessment Score 6 Hours After Treatment
Baseline to six hours after treatment

The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

Change From Baseline in the Itch Assessment Score 7 Days After Treatment
Baseline to seven days after treatment

The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

Secondary Endpoints

Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment
Baseline to Immediately following treatment
Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment
Baseline to one hour after treatment
Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment
Baseline to two hours after treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Positive ControlACTIVE_COMPARATORMarketed - EpiCeram(R) Skin Barrier Emulsion: Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin.
ExperimentalEXPERIMENTALNot Yet Marketed - 1% Colloidal Oatmeal Balm: Apply at least once per night or more if needed.

Interventions

NameTypeDescription
EpiCeram Skin Barrier EmulsionDEVICEEpiCeram Skin Barrier Emulsion
Experimental Product 1% Colloidal Oatmeal BalmDRUGExperimental Product 1% Colloidal Oatmeal Balm
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: 1. Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) 2. Male or female of any race or ethnicity, ages 12 and older 3. Diagnosed as having eczema 4. Willing to stop use of all non-assigned moisturizers and/or creams for ...

Countries:United States
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Frequently asked questions about Experimental Product 1% Colloidal Oatmeal Balm

What is Experimental Product 1% Colloidal Oatmeal Balm used for?

Experimental Product 1% Colloidal Oatmeal Balm is used for atopic dermatitis, a skin condition characterized by dry, itchy skin. It is being developed as a topical treatment for this dermatological condition.

Who makes Experimental Product 1% Colloidal Oatmeal Balm?

Experimental Product 1% Colloidal Oatmeal Balm is being developed by Johnson & Johnson, a company traded on the stock exchange under the ticker JNJ.

What phase is Experimental Product 1% Colloidal Oatmeal Balm in?

Experimental Product 1% Colloidal Oatmeal Balm is in Phase 2 of clinical development. It is an investigational product and has not yet been approved by regulatory authorities.

What clinical trials is Experimental Product 1% Colloidal Oatmeal Balm in?

Experimental Product 1% Colloidal Oatmeal Balm has one completed clinical trial, NCT02691507, which was a Phase 2 study. The trial enrolled 53 participants in the United States and evaluated the therapeutic benefit of the balm on dry, itchy skin in adults and children with eczema.

How does Experimental Product 1% Colloidal Oatmeal Balm work?

Experimental Product 1% Colloidal Oatmeal Balm contains 1% colloidal oatmeal as its active ingredient. Colloidal oatmeal is known for its skin-soothing properties, helping to relieve dryness and itching associated with atopic dermatitis.