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azelaic acid pre foam formulation

Phase 1

Healthy | Small molecule | Other |Bayer AG|Last Updated: Apr 1, 2020

Development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment240

FDA Designations

No designations recorded

Clinical trial landscape

azelaic acid pre foam formulation · 1 trial · 1 indication

Phase 1 1
NCT01430533Human Repeated Insult Patch Test (HRIPT) of Azelaic Acid Pre Foam FormulationHealthy
COMPLETED240 Analytics
PHASE1COMPLETED
Human Repeated Insult Patch Test (HRIPT) of Azelaic Acid Pre Foam Formulation
Healthy
NCT01430533240
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Study Endpoints

Primary Endpoints

skin sensitization reaction
day 3 to 6 of challenge phase week (week 6 or later, at least 2 weeks after the 3 week induction phase)

skin reactions will be assessed, using a standardized scoring scale

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
VerumEXPERIMENTALTopical application of verum (azelaic acid pre foam formulation) on the skin
VehiclePLACEBO_COMPARATORTopical application of vehicle formulation (same as verum but without active drug substance) on the skin
Negative controlPLACEBO_COMPARATORTopical application of distilled water (negative control) on the skin

Interventions

NameTypeDescription
azelaic acid pre foam formulationDRUG -
Vehicle pre foam formulationDRUG -
WaterDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * healthy volunteers * male or female subjects * aged 18 - 65 years * ability to understand and fulfill the study requirements Exclusion Criteria: * affected skin in designated test area * pregnancy or lactation * not willing to comply with study requirements

Countries:United States
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