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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 VulgarisUnlock trial analytics

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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Frequently asked questions about CTX-4430

What is CTX-4430 used for?

CTX-4430 is an investigational small molecule being developed for the treatment of moderate to severe facial acne vulgaris. It is currently in Phase 2 clinical development and has not been approved by the FDA.

Who makes CTX-4430?

CTX-4430 is being developed by CNS Pharmaceuticals, Inc., a company traded on the NASDAQ under the ticker symbol CNSP.

What phase is CTX-4430 in?

CTX-4430 is in Phase 2 clinical development. A Phase 2 trial for the treatment of moderate to severe facial acne vulgaris has been completed.

What clinical trials is CTX-4430 in?

CTX-4430 has been studied in a completed Phase 2 clinical trial with the identifier NCT02385760. This trial enrolled 124 participants with moderate to severe facial acne vulgaris and was conducted in Australia and New Zealand.

Is CTX-4430 the same as any other drug?

CTX-4430 is the primary name used for this investigational drug. No alternative names have been reported in clinical trial records.