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Dermacyd PH_DETINBACK

Phase 3

Hygiene | Small molecule | Other |Sanofi|Last Updated: Aug 25, 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 Trials2
Total Enrollment79
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00785720Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Photo AvaluationPHASE3 COMPLETED 26 — — Aug 1, 2008Sep 1, 2008Aug 25, 20091 Brazil
NCT00785681Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - CompatibilityPHASE3 COMPLETED 53 — — Jul 1, 2008Sep 1, 2008Aug 25, 20091 Brazil
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Study Endpoints
Primary Endpoints
The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. The sensibility will be evaluated according to the skin type.
Throughout the study
The absence of primary and accumulated dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
Throughout the study
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
1EXPERIMENTALDermacyd PH\_DETINBACK (Lactic Acid)
Interventions
NameTypeDescription
Dermacyd PH_DETINBACK (Lactic Acid)DRUG -
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Eligibility Criteria
Age Range18 Years — 60 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * Phototype Skin II and III; * Integral skin test in the region; * Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion; Exclusion criteria: * Lactation or gestatio...

Countries:Brazil
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