NCT02385760
Completed
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- CTX-4430
- Conditions
- Acne Vulgaris
- Sponsor
- Celtaxsys, Inc.
- Enrollment
- 124
- Locations
- 10
- Primary Endpoint
- Efficacy as measured by inflammatory lesion counts
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Active
CTX-4430 oral capsule, 100 mg, once-daily for 12 weeks
Intervention: CTX-4430
Placebo
Placebo: identical oral capsule, without active ingredient, once-daily for 12 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Efficacy as measured by inflammatory lesion counts
Time Frame: 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
Time Frame: 12 weeks
Incidence of treatment emergent adverse events as compared to placebo.
Secondary Outcomes
- Efficacy as measured by Investigator Global Assessment (IGA)(12 weeks)
- Efficacy as measured by non-inflammatory lesion counts(12 weeks)
Study Sites (10)
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