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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
124
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
Efficacy as measured by inflammatory lesion counts
Change from baseline in inflammatory lesion count after 12 weeks of treatment as compared to placebo.
Time frame: 12 weeks
Safety as measured by the incidence of treatment emergent adverse events
Incidence of treatment emergent adverse events as compared to placebo.
Time frame: 12 weeks
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.
Time frame: 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.
Time frame: 12 weeks
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