This study will evaluate the safety and efficacy of two different types of botulinum toxin type A for the treatment of glabellar frown lines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
224
20 units (total dose) botulinum toxin type A injected into glabellar region on Day 0
30 units (total dose) botulinum toxin type A injected into glabellar region on Day 0
Unnamed facility
Munich, Bavaria, Germany
Number of Subjects With a Treatment Response at Day 28 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the Facial Wrinkle Scale (FWS)
Number of subjects with a treatment response at Day 28 based on the injector's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.
Time frame: Day 28
Number of Subjects With a Treatment Response at Day 84 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS
Number of subjects with a treatment response at Day 84 based on the injector's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.
Time frame: Day 84
Number of Subjects With a Treatment Response at Day 98 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS
Number of subjects with a treatment response at Day 98 based on the injector's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.
Time frame: Day 98
Number of Subjects With a Treatment Response at Day 112 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS
Number of subjects with a treatment response at Day 112 based on the injector's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.
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Time frame: Day 112
Number of Subjects With a Treatment Response at Day 28 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS
Number of subjects with a treatment response at Day 28 based on the subject's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.
Time frame: Day 28
Number of Subjects With a Treatment Response at Day 84 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS
Number of subjects with a treatment response at Day 84 based on the subject's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.
Time frame: Day 84
Number of Subjects With a Treatment Response at Day 98 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS
Number of subjects with a treatment response at Day 98 based on the subject's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.
Time frame: Day 98
Number of Subjects With a Treatment Response at Day 112 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS
Number of subjects with a treatment response at Day 112 based on the subject's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.
Time frame: Day 112