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Supplemented Formula

Phase 3

Atopic Dermatitis | Unknown | Dermatology |Johnson & Johnson|Last Updated: Apr 16, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment380

FDA Designations

No designations recorded

Clinical trial landscape

Supplemented Formula · 1 trial · 1 indication

Phase 3 1
NCT02116452Prebiotics in Prevention of AtopyAtopic Dermatitis
COMPLETED380 Analytics
PHASE3COMPLETED
Prebiotics in Prevention of Atopy
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Cumulative incidence
36 - 48 weeks

Cumulative incidence of atopic dermatitis at 36 and 48 weeks

Secondary Endpoints

Severity
36-48 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Breast MilkNO_INTERVENTIONBreast FED newborns
Standard FormulaPLACEBO_COMPARATORStandard Formula FED newborns
Supplemented FormulaACTIVE_COMPARATORGOS/PDX Formula FED newborns

Interventions

NameTypeDescription
Supplemented FormulaDIETARY_SUPPLEMENT50:50 mixture of GOS/PDX formula will be administered
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Eligibility Criteria

Age Range1 Week to 24 Weeks
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Gestational age \>37 and \< 42 weeks. 2. Birth weight \> 2500 gr. 3. At risk of atopy (see appendix 1). 4. Informed consent signed by the parents (see appendix 3). Exclusion Criteria: 1. Congenital immunodeficiency 2. Severe congenital disorders or malformations 3. Born to ...

Countries:Italy
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Frequently asked questions about Supplemented Formula

What is Supplemented Formula used for in Atopic Dermatitis?

Supplemented Formula is an investigational product being studied for the prevention of atopic dermatitis in infants. It was evaluated in a Phase 3 clinical trial in Italy with 380 participants, where it was tested against a placebo to assess its effect on reducing the risk of developing this skin condition.

Who makes Supplemented Formula?

Supplemented Formula is being developed by Johnson & Johnson, a company traded on the stock exchange under the ticker symbol JNJ. The company conducted a Phase 3 clinical trial of this product for atopic dermatitis prevention.

What phase is Supplemented Formula in?

Supplemented Formula is in Phase 3 clinical development. A Phase 3 trial, NCT02116452, has been completed, which studied the product in 380 participants for the prevention of atopic dermatitis. The product is investigational and not yet approved for use.

What clinical trials is Supplemented Formula in?

Supplemented Formula has one completed clinical trial, NCT02116452, titled 'Prebiotics in Prevention of Atopy'. This Phase 3, randomized, double-blind, placebo-controlled study enrolled 380 participants with atopic dermatitis in Italy, with participants as young as 1 week old.

Is Supplemented Formula FDA approved?

Supplemented Formula is not FDA approved. It is an investigational product that has completed a Phase 3 clinical trial for atopic dermatitis prevention, but approval status has not been established. The product remains in clinical development.