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Dexpanthenol foam, new formulation

Phase 2

Erythema | Small molecule | Dermatology |Bayer AG|Last Updated: Oct 15, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment55

FDA Designations

No designations recorded

Clinical trial landscape

Dexpanthenol foam, new formulation · 2 trials · 2 indications

Phase 2 2
NCT00839462Efficacy of Dexpanthenol in Thermic ErythemaErythema
COMPLETED55 Analytics
NCT00839280Moisturizing Effect of Two Dexpanthenol FormulationsSkin Abnormalities
COMPLETED19 Analytics
PHASE2COMPLETED
Efficacy of Dexpanthenol in Thermic Erythema
ErythemaUnlock trial analytics
PHASE2COMPLETED
Moisturizing Effect of Two Dexpanthenol Formulations
Skin AbnormalitiesUnlock trial analytics

Study Endpoints

Primary Endpoints

Global sum of scores for evaluating the cooling/soothing effect evaluated after first and second application
2 min, 5 min, 10 min, 15 min
Area Under Curve (AUC) of the cutaneous hydration rate measured with corneometer between T0 and T5h
0 min, 15 min, 30 min, 1h, 2h, 3h, 5h

Secondary Endpoints

Skin temperature
2 min, 5 min, 10 min
Evaluation of the cooling/soothing effect (scores) after first and second application
2 min, 5min, 10 min, 15 min
Evaluation of the foam covering properties after first application
2 min, 5 min, 10 min, 15 min
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Dexpanthenol foam spray, new formulationDRUG2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter
Dexpanthenol foam spray, old formulationDRUG2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy subjects * Phototype: I to IV according to Fitzpatrick scale Exclusion Criteria: * Pregnant or nursing women * Subjects registered as being in exclusion period in the French Health Minister file of subjects * Subjects with known allergy to cosmetics, skin care produc...

Countries:France
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Frequently asked questions about Dexpanthenol foam, new formulation

What is Dexpanthenol foam, new formulation used for?

Dexpanthenol foam, new formulation is an investigational small molecule being studied for dermatology conditions including skin abnormalities and erythema, or redness of the skin. It is being developed by Bayer AG (ticker: BAYRY) and is currently in Phase 2 clinical development.

Who makes Dexpanthenol foam, new formulation?

Dexpanthenol foam, new formulation is being developed by Bayer AG, a pharmaceutical company traded under the ticker BAYRY. The drug is in Phase 2 clinical development for dermatology indications such as skin abnormalities and erythema.

What phase is Dexpanthenol foam, new formulation in?

Dexpanthenol foam, new formulation is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for skin abnormalities and erythema.

What clinical trials is Dexpanthenol foam, new formulation in?

Dexpanthenol foam, new formulation has been studied in two completed Phase 2 clinical trials. NCT00839280 evaluated its moisturizing effect in 19 healthy volunteers with skin abnormalities in France. NCT00839462 assessed its efficacy in 55 healthy volunteers with erythema in France. Both trials were randomized, double-blind, and active-controlled.

Is Dexpanthenol foam, new formulation the same as dexpanthenol?

Dexpanthenol foam, new formulation is a formulation of dexpanthenol, a small molecule. The clinical trials NCT00839280 and NCT00839462 studied the moisturizing and anti-redness effects of this specific foam formulation in healthy volunteers with skin abnormalities and erythema.