CTX-4430 for the Treatment of Moderate to Severe Facial Acne Vulgaris
NCT ID: NCT02385760
Last Updated: 2016-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2015-04-30
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active
CTX-4430 oral capsule, 100 mg, once-daily for 12 weeks
CTX-4430
Placebo
Placebo: identical oral capsule, without active ingredient, once-daily for 12 weeks
Placebo
Interventions
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CTX-4430
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Male or female aged 16 to 44 inclusive.
3. Moderate to severe facial acne vulgaris as defined in the protocol.
Exclusion Criteria
2. Females who are pregnant, lactating, or planning to become pregnant during the study.
3. Any systemic medical condition which, in the opinion of the investigator, would put the participant at risk by participation in the study.
4. Any systemic or dermatologic disorder that, in the opinion of the investigator will interfere with the assessment of the study endpoints (e.g. psoriasis).
5. Concurrent or previous use of an investigational drug or device within 30 days prior to screening.
6. The presence of acne conglobata, acne fulminans, secondary acne, or nodulocystic acne.
7. The presence of known or suspicious unresolved dermatological cancerous or pre-cancerous lesions.
8. Hypersensitivity or idiosyncratic reaction to compounds related to CTX-4430 or any of its components.
16 Years
44 Years
ALL
No
Sponsors
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Clinical Network Services (CNS) Pty Ltd
INDUSTRY
Celtaxsys Aus Pty Limited
INDUSTRY
Celtaxsys, Inc.
OTHER
Responsible Party
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Principal Investigators
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Lynda J Spelman, MB BS, FACD
Role: PRINCIPAL_INVESTIGATOR
Veracity Clinical Research
Locations
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Clinical Trials Woden Dermatology
Phillip, Australian Capital Territory, Australia
St George Dermatology
Kogarah, New South Wales, Australia
Central Sydney Dermatology
Sydney, New South Wales, Australia
The Skin Centre
Benowa, Queensland, Australia
Siller Medical
Brisbane, Queensland, Australia
Veracity Clinical Research
Woolloongabba, Queensland, Australia
Skin and Cancer Foundation
Carlton, Victoria, Australia
Fremantle Dermatology
Fremantle, Western Australia, Australia
Optimal Clinical Trials
Auckland, , New Zealand
Clinical Trials New Zealand
Hamilton, , New Zealand
Countries
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Other Identifiers
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CTX-4430-AV-201
Identifier Type: -
Identifier Source: org_study_id
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