This is a blinded, randomized study in the US to compare the duration response of two different concentrations of BOTOX in healthy female subjects with moderate to severe dynamic glabellar lines on maximum frown.
This study involves a blinded, randomized, parallel-group design. The aim of this study is to evaluate the duration response of BOTOX in subjects with moderate to severe dynamic glabellar lines at the approved on-label dose of 20 U, however comparing the use of highly Concentrated On Label Dose (COLD) to the On Label Dose and concentration (OLD). The COLD concentration is defined as 4 Units per 0.02 mL and the OLD concentration is defined as 4 Units per 0.1 mL. The total BOTOX dose will be 20U divided into 5 injections for both study groups. However, the injection volume will differ for the two study groups, such that the OLD (4 U per 0.1 mL) group will receive a total of 0.5 mL and the COLD (4 U per 0.02 mL) group will receive a total of 0.1mL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Injection of glabellar rhytids
Clinical Testing of Beverly Hills
Encino, California, United States
RECRUITINGSteve Yoelin MD
Newport Beach, California, United States
RECRUITINGResponse Duration
Time to return to baseline Facial Wrinkle Scale (FWS) score at maximum frown, as assessed by the blinded evaluating investigator. The Facial Wrinkle Scale (FWS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles.
Time frame: 180 days
Investigator Live Assessment (Dynamic)
Responder rate at each visit on the Facial Wrinkle Scale (FWS) at maximum frown, as assessed by the blinded evaluating investigator. The responder rate is defined as the proportion of subjects maintaining a greater than or equal to 1 point improvement on the FWS. The Facial Wrinkle Scale (FWS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles.
Time frame: 180 days
Subject Self Assessment (Dynamic)
Responder rate at each visit on the Facial Wrinkles Scale (FWS) at maximum frown, as assessed by the subject. The Facial Wrinkle Scale (FWS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles.
Time frame: 180 days
Investigator Live Assessment (At Rest)
Responder rate at each visit on the Facial Wrinkle Scale (FWS) at rest, as assessed by the blinded evaluating investigator. The Facial Wrinkle Scale (FWS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles.
Time frame: 180 days
Subject Self Assessment (At Rest)
Responder rate at each visit on the Facial Wrinkle Scale (FWS) at rest, as assessed by the subject. The Facial Wrinkle Scale (FWS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles.
Time frame: 180 days
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Change from Baseline Score
Change from baseline in mean Facial Wrinkle Scale (FWS) score at maximum frown, as assessed by the blinded evaluating investigator, at each visit. The Facial Wrinkle Scale (FWS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles.
Time frame: 180 days
Change in Frontalis Function
Percentage of subjects with weakening of frontalis muscle function using the Frontalis Function Scale (FFS) compared to baseline, as assessed by the blinded evaluating investigator, at each visit. The Frontalis Function Scale (FFS) scale ranges from a score of 0 to 3, and a higher score indicates greater reduction of forehead movement during maximal brow raise.
Time frame: 180 days