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Dexpanthenol foam, new formulation

Phase 2

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

Target and mechanism

ModalitySmall molecule

Also known as Dexpanthenol foam spray, new formulation

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?

Dexpanthenol foam, new formulation is a small molecule dermatology product developed by Bayer AG. It is being studied in Phase 2 clinical trials for erythema and skin abnormalities. The formulation is applied as a foam and has been evaluated in two completed Phase 2 trials conducted in France.

What is dexpanthenol foam, new formulation used for?

Dexpanthenol foam, new formulation is being developed for erythema, which is skin redness, and for skin abnormalities. The clinical program has focused on these dermatological conditions. One trial examined its efficacy in thermic erythema, while another assessed the moisturizing effect of two dexpanthenol formulations.

Who makes dexpanthenol foam, new formulation?

Bayer AG is the developer of dexpanthenol foam, new formulation. Bayer AG trades on the OTC market under the ticker BAYRY. The company is responsible for the clinical development of this dermatology asset.

What phase is dexpanthenol foam, new formulation in?

Dexpanthenol foam, new formulation is in Phase 2 clinical development. Two Phase 2 trials have been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is dexpanthenol foam, new formulation in?

Dexpanthenol foam, new formulation has been studied in two completed Phase 2 trials. NCT00839462 evaluated its efficacy in thermic erythema with 55 participants in France. NCT00839280 assessed the moisturizing effect of two dexpanthenol formulations with 19 participants, also in France. Both trials enrolled healthy volunteers.

Is dexpanthenol foam, new formulation the same as dexpanthenol foam spray, new formulation?

Yes, dexpanthenol foam, new formulation is also known as dexpanthenol foam spray, new formulation. These names refer to the same Bayer AG product candidate being studied for erythema and skin abnormalities in Phase 2 trials.