Conditions: Acne Vulgaris
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 490
Healthy volunteers: no

Brief summary:
Open-label study will evaluate the safety of an approximate 1.5 mg/kg/day dose of oral sarecycline in the long-term treatment of participants with moderate to severe facial acne vulgaris.

Detailed description:

Arms:
arm 1: Participants received placebo-matching sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 milligram(mg)/kilogram(kg) sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks). arm 2: Participants received sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).

Interventions: intervention 1: Sarecycline
Intervention descriptions: intervention 1: Administered based on participant's body weight.

Protocol document: