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Dermacid Silver

Phase 3

Hygiene | Small molecule | Other |Sanofi|Last Updated: Dec 2, 2010

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment70
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01126606Comparative Safety and Efficacy Evaluation Between Dermacyd Silver and Glycerine Vegetal Soap Granado TraditionalPHASE3 COMPLETED 70Aug 1, 2010Nov 1, 2010Dec 2, 20101 Brazil
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Study Endpoints
Primary Endpoints
Transepidermal water loss measurement (TEWL) and corneometry
Up to Week 9

Measures taken at all visits by Tewameter equipment TM 300. The value of the average will be considered for analysis of final results. Corneometry: Measures taken at all visits by Corneometer equipment MPA 580.

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTALDermacyd Silver Frutal followed by Dermacyd Silver Frutal+PH\_DESYLSTY\_FR followed by wash out followed by Glycerine Vegetal Soap Granado Traditional
Group 2EXPERIMENTALGlycerine Vegetal Soap Granado Traditional followed by wash out followed by Dermacyd Silver Floral followed by Dermacyd Silver Floral + PH\_DESYLSTY\_FR
Interventions
NameTypeDescription
Dermacid Silver (Lactic acid)DRUGLiquid soap, daily use
Glycerine Vegetal Soap Granado TraditionalDRUGVegetal soap, daily use
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Eligibility Criteria
Age Range45 Years — 65 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Active sex life * Menopause for at least 6 months * Perfect mucosa in the evaluated area * Use the same cosmetics category Exclusion criteria: * Use of antiinflammatory / immunosuppression / antihistaminic drugs * Personal history of atopy to cosmetic products * Cutaneous ac...

Countries:Brazil
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