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| Name | Class |
|---|---|
| Clinical Network Services (CNS) Pty Ltd | INDUSTRY |
| Celtaxsys Aus Pty Limited | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | CTX-4430 oral capsule, 100 mg, once-daily for 12 weeks |
|
| Placebo | Placebo Comparator | Placebo: identical oral capsule, without active ingredient, once-daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTX-4430 | Drug |
| ||
| Placebo |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynda J Spelman, MB BS, FACD | Veracity Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Woden Dermatology | Phillip | Australian Capital Territory | 2606 | Australia | ||
| St George Dermatology |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C000625351 | acebilustat |
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|
Change from baseline in non-inflammatory lesion counts after 12 weeks of treatment as compared to placebo. |
| 12 weeks |
| Kogarah |
| New South Wales |
| 2217 |
| Australia |
| Central Sydney Dermatology | Sydney | New South Wales | 2000 | Australia |
| The Skin Centre | Benowa | Queensland | 4217 | Australia |
| Siller Medical | Brisbane | Queensland | 4000 | Australia |
| Veracity Clinical Research | Woolloongabba | Queensland | 4102 | Australia |
| Skin and Cancer Foundation | Carlton | Victoria | 3053 | Australia |
| Fremantle Dermatology | Fremantle | Western Australia | 6160 | Australia |
| Optimal Clinical Trials | Auckland | New Zealand |
| Clinical Trials New Zealand | Hamilton | 3210 | New Zealand |