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Dexpanthenol

Phase 1

Undisclosed | Small molecule | Other |Bayer AG|Trials Updated: Jun 23, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Dexpanthenol clinical trials

Dexpanthenol · 1 trial · 1 indication

Phase 1 1
NCT00885937Comparative Safety Study of New Sinecort Formulation Versus Positive ControlHealthy
COMPLETED33 Analytics
PHASE1COMPLETED
Comparative Safety Study of New Sinecort Formulation Versus Positive Control
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Study Endpoints

Primary Endpoints

Irritation rate
After 21 applications

Secondary Endpoints

Irritation potential
After 21 applications
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2ACTIVE_COMPARATOR -
Arm 3PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Dexpanthenol (Sinecort, BAY81-2996)DRUG1 squeeze of Sinecort cream sufficient to cover the area of the application chamber, (=50 mikro liter)
Positive control, Na-laurylsulfat-solutionDRUG50 mikro liter of 0.5 % Sodium-laurylsulfate-solution
Untreated skin under application chamberDEVICEApplication of treatment chamber as in arm 1 and arm 2 on untreated skin
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Age of at least 18 years * Skin type I, II, or III according to Fitzpatrick * Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods o...

Countries:Germany
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Frequently asked questions about Dexpanthenol

What is Dexpanthenol?

Dexpanthenol is a small molecule drug being developed by Bayer AG under the code BAY81-2996. It is also known by the name Sinecort. It has been studied in a Phase 1 clinical trial, and the specific therapeutic indication has not been disclosed.

Who makes Dexpanthenol?

Dexpanthenol is developed by Bayer AG, which trades under the ticker BAYRY. The drug is also referred to as Sinecort or by the development code BAY81-2996.

What phase is Dexpanthenol in?

Dexpanthenol is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are currently no active trials. It is an investigational drug and has not been approved by the FDA.

What clinical trials is Dexpanthenol in?

Dexpanthenol has been evaluated in one completed Phase 1 trial, NCT00885937, titled a comparative safety study of a new Sinecort formulation versus positive control. The trial enrolled 33 healthy adult volunteers in Germany and was randomized and placebo-controlled.

Is Dexpanthenol the same as Sinecort?

Yes, Dexpanthenol is also known as Sinecort and by the development code BAY81-2996. These names refer to the same small molecule drug developed by Bayer AG.