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Dermacyd Femina Pocket BR

Phase 3

Hygiene | Small molecule | Other |Sanofi|Last Updated: Dec 19, 2008

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00794612Dermacyd Femina Pocket BR (Lactic Acid)- Acceptability.PHASE3 COMPLETED 30Nov 1, 2008 -Dec 19, 20081 Brazil
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Study Endpoints
Primary Endpoints
Absence of irritation
From the start to the end of the study
Good acceptability
From the start to the end of the study
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
1EXPERIMENTALDermacyd Femina Pocket BR (Lactic Acid)
Interventions
NameTypeDescription
Dermacyd Femina Pocket BR (Lactic Acid)DRUGDermacyd Femina Pocket BR (Lactic Acid) during 21 consecutive days
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Eligibility Criteria
Age Range18 Years — 60 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * Integral skin test in the region; * To use products of the same category; Exclusion criteria: * Lactation or gestation; * Use of anti-inflammatory, anti-histaminic or immunosuppressant drugs; * Cutaneous disease (local or spread) in the evaluation area; * Pathology which may...

Countries:Brazil
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