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Dexpanthenol

Phase 1

Healthy | Small molecule | Other |Bayer AG|Last 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

Clinical trial landscape

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 used for?

Dexpanthenol is a small molecule being developed by Bayer AG for use in healthy volunteers. It is currently in Phase 1 clinical development as an investigational drug. The compound is being studied for its safety profile in a clinical trial setting, though no specific therapeutic indication has been established in the available data.

Who makes Dexpanthenol?

Dexpanthenol is being developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY. The company is conducting clinical research on this small molecule compound as part of its early-stage development pipeline.

What phase is Dexpanthenol in?

Dexpanthenol is currently in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The compound is in early-stage testing to evaluate its safety and tolerability in human subjects, which is the primary objective of Phase 1 trials.

What clinical trials is Dexpanthenol in?

Dexpanthenol has one completed Phase 1 clinical trial registered under NCT00885937. This trial, titled "Comparative Safety Study of New Sinecort Formulation Versus Positive Control," enrolled 33 healthy volunteers in Germany. The study was placebo-controlled and randomized, though it was not double-blinded. The trial has been completed.

Is Dexpanthenol FDA approved?

Dexpanthenol is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The compound has completed one early-stage clinical trial, but it has not yet demonstrated sufficient safety and efficacy data to support regulatory approval. Further clinical studies would be required before any approval could be considered.