Acne vulgaris
Conditions
Brief summary
Nature, incidence and severity of adverse events (AEs), along with changes in laboratory safety parameters, vital signs, physical examination, and body weight., Nature, incidence, and severity of skin reactions at the application site, Proportion of successes according to IGA score at week 8., Absolute change in number of inflammatory lesions at week 8., Absolute change in number of noninflammatory lesions at week 8.
Detailed description
Proportion of successes according to IGA score at weeks 4 and 12., Absolute change in number of inflammatory lesions at wees 4 and 12., Absolute change in number of noninflammatory lesions at weeks 4 and 12., Percent change in number of inflammatory lesions at weeks 4, 8 and 12., Percent change in number of noninflammatory lesions at weeks 4, 8 and 12, Establish pharmacokinetics of AT-004 in a subset of 5 participants., Change in Dermatology Life Quality Index (DLQI) score from baseline to weeks 4, 8 and 12., Reduction in DLQI of >4 points from baseline to week 8 and 12 among subjects with baseline DLQI >4
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nature, incidence and severity of adverse events (AEs), along with changes in laboratory safety parameters, vital signs, physical examination, and body weight., Nature, incidence, and severity of skin reactions at the application site, Proportion of successes according to IGA score at week 8., Absolute change in number of inflammatory lesions at week 8., Absolute change in number of noninflammatory lesions at week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of successes according to IGA score at weeks 4 and 12., Absolute change in number of inflammatory lesions at wees 4 and 12., Absolute change in number of noninflammatory lesions at weeks 4 and 12., Percent change in number of inflammatory lesions at weeks 4, 8 and 12., Percent change in number of noninflammatory lesions at weeks 4, 8 and 12, Establish pharmacokinetics of AT-004 in a subset of 5 participants., Change in Dermatology Life Quality Index (DLQI) score from baseline to weeks 4, 8 and 12., Reduction in DLQI of >4 points from baseline to week 8 and 12 among subjects with baseline DLQI >4 | — |
Countries
Denmark