Conditions: Acne Vulgaris
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 257
Healthy volunteers: no

Brief summary:
Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the Investigator's Global Assessment (IGA) score and the absolute change from baseline in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline in non-inflammatory and total lesions of the active study medication to placebo will be evaluated.

Detailed description:

Arms:
arm 1: Doxycycline dosed at 40 mg/day to subjects of appropriate weights arm 2: Doxycycline dosed at 80 mg/day to subjects of appropriate weights arm 3: Doxycycline dosed at 160 mg/day to subjects of appropriate weights arm 4: None

Interventions: intervention 1: Doxycycline 0.6 mg/kg/day intervention 2: Doxycycline 1.2 mg/kg/day intervention 3: Doxycycline 2.4 mg/kg/day intervention 4: Placebo
Intervention descriptions: intervention 1: doxycycline 40 mg/day, oral, 12 weeks intervention 2: doxycycline 80 mg/day, 12 weeks intervention 3: doxycycline 160 mg/day, 12 weeks intervention 4: Placebo, 12 weeks

Protocol document: