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DMT210

Phase 2

Atopic Dermatitis | Small molecule | Immunology |Dermata Therapeutics, Inc.|Last Updated: Apr 18, 2018

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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment19
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02949960DMT210 Topical Gel in the Treatment of Atopic DermatitisPHASE2 COMPLETED 19Oct 1, 2016Jul 14, 2017Apr 18, 20182 United States
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Study Endpoints
Primary Endpoints
ADSI (Atopic Dermatitis Severity Index) score of each Target lesion
Day 28

Change from baseline in ADSI score between Vehicle and 5% gel

Secondary Endpoints
Individual Signs and Symptoms of Atopic Dermatitis of each Target Lesion
Day 28
Investigator Global Assessment (IGA) of the Treatment Area
Day 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DMT210 Topical GelEXPERIMENTALDMT210 Topical Gel 5% applied to target lesion twice daily
Vehicle ControlPLACEBO_COMPARATORTopical Gel vehicle applied to target lesion twice daily
Interventions
NameTypeDescription
DMT210 Topical GelDRUGDMT210 Topical Aqueous Gel 5% applied twice daily
Vehicle ControlDRUGTopical Vehicle Gel applied twice daily
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Male or female 12 years or older * Patient has chronic, stable AD that has been present for at least 3 months with 5-35% (inclusive) BSA (Body Surface Area) of AD involvement * Patient has two analogous, Target Lesions; one lesion within each of the two Treatment Areas * Patie...

Countries:United States
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