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Dermacyd PH_DETINLYN Sweet Flower

Phase 3

Hygiene | Small molecule | Other |Sanofi|Last Updated: Mar 6, 2009

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 Enrollment31
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00785148Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid) - SafetyPHASE3 COMPLETED 31Aug 1, 2008 -Mar 6, 20091 Brazil
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Study Endpoints
Primary Endpoints
The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction.
From treatment start to the end of study
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
1EXPERIMENTALDermacyd PH\_DETINLYN Sweet Flower (Lactic Acid)
Interventions
NameTypeDescription
Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid)DRUG -
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Eligibility Criteria
Age Range10 Years — 20 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Integral skin test in the region, * Use of cosmetic product of the same category Exclusion Criteria: * Lactation or gestational risk or gestation * Use of Anti-inflammatory, immunosuppression or anti-histaminic drugs * Atopic antecedent or allergic to cosmetic product * Acti...

Countries:Brazil
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