Conditions: Acne Vulgaris
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 36
Healthy volunteers: no

Brief summary:
This is a single center, randomized, double-blind, placebo-controlled study in subjects with acne vulgaris.

Detailed description:
After a screening visit and a one-week washout (if applicable), three sequential ascending doses of the study drug will be applied twice-daily (BID) for 14 days in three groups of subjects. Each group of subjects will be randomized to receive the planned doses of B244 or placebo BID

Arms:
arm 1: B244 Dose 1 (dose level \[cells/mL\] 20,000,000,000) arm 2: B244 Dose 2 (dose level \[cells/mL\] 40,000,000,000) arm 3: B244 Dose 3 (dose level \[cells/mL\] 80,000,000,000) arm 4: Placebo to Match B244

Interventions: intervention 1: B244 intervention 2: Placebo
Intervention descriptions: intervention 1: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days intervention 2: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days

Protocol document: