CTX-4430 for the Treatment of Moderate to Severe Facial Acne Vulgaris

Study Overview
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Brief Summary
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A multi-centre, double-blind, randomized, parallel group, placebo controlled efficacy and safety study of oral CTX-4430 for the treatment of moderate to severe facial acne vulgaris.

Official Title
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A Multi-centre, Double-blind, Randomized, Parallel Group, Placebo Controlled Efficacy and Safety Study of Oral CTX-4430 for the Treatment of Moderate to Severe Facial Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: CTX-4430
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must provide Informed consent. Male or female aged 16 to 44 inclusive. Moderate to severe facial acne vulgaris as defined in the protocol. Exclusion Criteria: Positive testing for HIV, HBsAg, or hepatitis C virus (HCV). Females who are pregnant, lactating, or planning to become pregnant during the study. Any systemic medical condition which, in the opinion of the investigator, would put the participant at risk by participation in the study. Any systemic or dermatologic disorder that, in the opinion of the investigator will interfere with the assessment of the study endpoints (e.g. psoriasis). Concurrent or previous use of an investigational drug or device within 30 days prior to screening. The presence of acne conglobata, acne fulminans, secondary acne, or nodulocystic acne. The presence of known or suspicious unresolved dermatological cancerous or pre-cancerous lesions. Hypersensitivity or idiosyncratic reaction to compounds related to CTX-4430 or any of its components.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>CTX-4430 oral capsule, 100 mg, once-daily for 12 weeks | Drug: CTX-4430<br> <br> |
| Placebo Comparator: Placebo<br>Placebo: identical oral capsule, without active ingredient, once-daily for 12 weeks | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as measured by inflammatory lesion counts | Change from baseline in inflammatory lesion count after 12 weeks of treatment as compared to placebo. | 12 weeks | 
| Safety as measured by the incidence of treatment emergent adverse events | Incidence of treatment emergent adverse events as compared to placebo. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as measured by Investigator Global Assessment (IGA) | The proportion of participants achieving Grade 0 or 1 with a two grade improvement in the IGA from baseline to the end of the 12 weeks of treatment as compared to placebo. | 12 weeks | 
| Efficacy as measured by non-inflammatory lesion counts | Change from baseline in non-inflammatory lesion counts after 12 weeks of treatment as compared to placebo. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Facial Acne