Acne Vulgaris
Conditions
Brief summary
The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of acne.
Interventions
single dose application
Sponsors
Study design
Eligibility
Inclusion criteria
* diagnosis of moderate to severe facial acne * 15 to 40 papules and pustules, and 5 to 50 open and/or closed comedones * no presence of nodules * female subjects must be not pregnant and non-lactating
Exclusion criteria
* presence of 1 or more nodules * use of topical steroids on the face 4 weeks prior and during the study * use of systemic corticosteroids 6 weeks prior and during the study * topical or systemic acne treatment in the 4 weeks prior to Baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy will be assessed by lesion count. | Week 4 | inflammatory lesion count (papules, pustules, and nodules) and non-inflammatory lesion count (open and closed comedones) |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Investigator Global Assessment Score | Week 1, 2, 4, 8, and 12 |
| Change from Baseline in Lesion Count | Week 1, 2, 4, 8, 12 |
Countries
United States