The purpose of this study is to determine the efficacy and safety of oral sarecycline 1.5 mg/kg/day in truncal acne. Patients with moderate to severe acne vulgaris will be observed over a period of 12 weeks. Lesion counts, investigator's global assessments, photography, and safety measures will be assessed for the trunk and face.
Study Type
OBSERVATIONAL
Enrollment
10
60 mg sarecycline tablets will be given for subjects with a body weight of 33 to 54 kg, 100 mg sarecycline tablets will be given for subjects with a body weight of 55 to 84 kg, and 150 mg tablets will be given for subjects with a body weight between 85 and 136 kg.
Arlington Research Center
Arlington, Texas, United States
Change from Baseline in Acne Severity Based on Investigator's Global Assessment Success
Investigator's Global Assessment (IGA) success for truncal acne vulgaris at week 12
Time frame: Baseline, Week 12
Change from Baseline in Absolute Lesion Count
Absolute change from baseline lesion counts for inflammatory acne for truncal acne vulgaris at week 12
Time frame: Baseline, Week 12
Adverse Events and Adverse Events of Special Interest
Safety based on adverse events (AEs), adverse events of special interest (AESI), vital signs, and physical examinations
Time frame: Baseline, Week 12
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