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CTX-4430

Phase 2

Acne Vulgaris | Small molecule | Dermatology |CNS Pharmaceuticals, Inc.|Last Updated: Aug 2, 2016

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment124
FDA Designations
No designations recorded
Clinical trial landscape

CTX-4430 · 1 trial · 1 indication

Phase 2 1
NCT02385760CTX-4430 for the Treatment of Moderate to Severe Facial Acne VulgarisAcne Vulgaris
COMPLETED124 Analytics
PHASE2COMPLETED
CTX-4430 for the Treatment of Moderate to Severe Facial Acne Vulgaris
Acne Vulgaris
NCT02385760124
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Study Endpoints
Primary Endpoints
Efficacy as measured by inflammatory lesion counts
12 weeks

Change from baseline in inflammatory lesion count after 12 weeks of treatment as compared to placebo.

Safety as measured by the incidence of treatment emergent adverse events
12 weeks

Incidence of treatment emergent adverse events as compared to placebo.

Secondary Endpoints
Efficacy as measured by Investigator Global Assessment (IGA)
12 weeks
Efficacy as measured by non-inflammatory lesion counts
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ActiveEXPERIMENTALCTX-4430 oral capsule, 100 mg, once-daily for 12 weeks
PlaceboPLACEBO_COMPARATORPlacebo: identical oral capsule, without active ingredient, once-daily for 12 weeks
Interventions
NameTypeDescription
CTX-4430DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range16 Years to 44 Years
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: 1. Must provide Informed consent. 2. Male or female aged 16 to 44 inclusive. 3. Moderate to severe facial acne vulgaris as defined in the protocol. Exclusion Criteria: 1. Positive testing for HIV, HBsAg, or hepatitis C virus (HCV). 2. Females who are pregnant, lactating, or pl...

Countries:AustraliaNew Zealand
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