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RD047-26

Phase 2

Atopic Dermatitis | Unknown | Immunology |Sonoma Pharmaceuticals, Inc.|Last Updated: May 30, 2012

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 Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01232985Efficacy and Tolerability Study of Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis in AdultsPHASE2 COMPLETED 17Oct 1, 2010Dec 1, 2010May 30, 20121 United States
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Study Endpoints
Primary Endpoints
Investigator Global Assessment
2 weeks

Investigator Global Assessment of Atopic Dermatitis Severity

Secondary Endpoints
Investigator Pruritus Assessment
2 weeks
Subject Itch Assessment
2 weeks
Adverse Events
2 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RD047-26EXPERIMENTALStudy Device
Interventions
NameTypeDescription
RD047-26DEVICERD047-26 emollient gel
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Written informed consent * Female or male, 18 to 65 years of age and in good general health * Clinical diagnosis of stable mild to moderate atopic dermatitis * Willing and able to follow study instructions and likely to complete all study requirements Exclusion Criteria: * S...

Countries:United States
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