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betamethasone valerate

Phase 3

Atopic Eczema | Small molecule | Dermatology |Perrigo Company plc|Last Updated: Oct 13, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment55

FDA Designations

No designations recorded

Clinical trial landscape

betamethasone valerate · 1 trial · 1 indication

Phase 3 1
NCT00576238Skin Tolerance Study of Betamethasone Creams in Atopic Eczema and the Preventative Properties of a MoisturiserAtopic Eczema
COMPLETED55 Analytics
PHASE3COMPLETED
Skin Tolerance Study of Betamethasone Creams in Atopic Eczema and the Preventative Properties of a Moisturiser
Atopic EczemaUnlock trial analytics

Study Endpoints

Primary Endpoints

To study the compatibility of the skin with the new formulation in comparison to the reference medication.
3 weeks
To study the effect of maintenance therapy with an emollient cream on the possible recurrence of atopic eczema.
Up to 6 months

Secondary Endpoints

To study cosmetic acceptance of the corticosteroids
3 weeks
To study the safety of corticosteroid treatment.
3 weeks
To study the safety of maintenance treatment.
Up to 6 months.
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1:1EXPERIMENTALPart 1 - eczema treatment
1:2ACTIVE_COMPARATORPart 1 - eczema treatment
2:1EXPERIMENTALPart 2 - maintenance treatment
2:2NO_INTERVENTIONPart 2 - maintenance treatment

Interventions

NameTypeDescription
betamethasone valerateDRUGTopical application according to a fixed schedule for three weeks
ureaDRUGTopical application twice daily for up to 6 months
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Females and males between 18 and 65 years of age * Caucasian * AD according to the criteria of Hanifin and Rajka (12) with eczematous lesions corresponding to an Atopic Dermatitis Severity Index (ADSI) (13) score of at least 6 on any of the following areas: arms, legs, chest, ...

Countries:Sweden
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Frequently asked questions about betamethasone valerate

What is betamethasone valerate used for in atopic eczema?

Betamethasone valerate is a small molecule being studied for the treatment of atopic eczema, a form of dermatitis. It is a topical corticosteroid intended to reduce skin inflammation and irritation associated with the condition. The drug is currently in Phase 3 clinical development for this indication.

What does betamethasone valerate target?

Betamethasone valerate is a corticosteroid that works by binding to glucocorticoid receptors in the skin, which modulates gene expression to reduce inflammation, itching, and redness. This mechanism helps manage the symptoms of atopic eczema by suppressing the local immune response and inflammatory mediators in affected skin areas.

Who makes betamethasone valerate?

Betamethasone valerate is being developed by Perrigo Company plc, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PRGO. Perrigo is conducting clinical research to evaluate the drug's safety and efficacy for treating atopic eczema.

What phase is betamethasone valerate in?

Betamethasone valerate is in Phase 3 clinical development for atopic eczema. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the company is likely analyzing the results to determine next steps toward potential regulatory submission.

What clinical trials is betamethasone valerate in?

Betamethasone valerate has one completed Phase 3 clinical trial registered as NCT00576238, titled 'Skin Tolerance Study of Betamethasone Creams in Atopic Eczema and the Preventative Properties of a Moisturiser.' This randomized, double-blind, active-controlled study enrolled 55 participants in Sweden and evaluated the drug's skin tolerance in adults aged 18 years and older.

Is betamethasone valerate the same as betamethasone?

Betamethasone valerate is a prodrug form of betamethasone, meaning it is a derivative that is converted into the active corticosteroid betamethasone in the body. While related, they are distinct chemical entities. Betamethasone valerate is specifically formulated for topical use to treat skin conditions like atopic eczema, offering improved skin penetration and local anti-inflammatory effects.