Sarecycline Truncal Acne Safety and Efficacy Response

A Single Center, Phase 4, Open-label Prospective Case Series Study of the Safety and Efficacy of Sarecycline for 12 Weeks in Subjects Ages 9 and Over With Truncal Acne

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.

Inclusion Criteria:

• Male or female age 9 or above.
• Clinical diagnosis of moderate to severe truncal acne based on IGA

Exclusion Criteria:

• Known or suspected allergies or sensitivities to any components of the study drug.
• Any disorders that would preclude the use of tetracycline-class antibiotics or sarecycline.
• Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the trial results and/or put the subject at significant risk (according to the Investigator's judgment) if the subject takes part in the trial.

Other protocol defined Inclusion/Exclusion criteria may apply.