The objective of this study is investigation of safety and efficacy of intramascular inection 50 U Botulinum toxin type A - MASPORT® - in compare to a commercial product- DYSPORT® - in adults with moderate to severe glabellar lines.
Study design:This study is a double-blind, randomized ,parallel group, active-controlled, phase 3 clinical trial.
Inclusion criteria: male or females; age 18 to 60 years with moderate to severe glabellar lines. Exclusion criteria: No sign of informed consent form; serious side effect; cardiovascular disorder; pulmonary infection/disorder; concomitant administration of neuromuscular drugs; face surgery or peeling.
Population: 260 volunteers will be recruiting in this study.
Intervention: Test group will receive 50 U of botulinum toxine type A -Masport intramascularly.The total dose will be injected in 5 different sites between glabellar lines.Active control group will receive 50 U of botulinum toxine type A -Dysport intramascularly.The total dose will be injected in 5 different sites between glabellar lines.
All volunteers will subjected to follow-up visits 14,30,60,90 and 120 days after injection and all side effects and efficacy assessments will record in CFR forms.
Primary outcome:Glabellar line improvement assessment by investigator on day 30 at maximum frown; Subject Global Assessment of Change (SGA) on day 30; Any side effects 0, 14 , 30,60,90 and 120 days after injection.secondary outcome: Glabellar line improvement assessment by investigator 60,90 and 120 days after injection at relax and maximum frown; Subject Global Assessment of Change (SGA) 60,90 and 120 days after injection.
All data will analysis to confirm the non-inferiority of MASPORT® to DYSPORT® in glabellar line improvement.