An interventional Phase 4 study to assess subject satisfaction with abobotulinumtoxinA treatment.
Following signature of informed consent and the screening process, eligible subjects were treated at the Baseline visit (Day 0) with abobotulinumtoxinA in the glabellar region. Subjects were re-treated at the Month 6 visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
120
AbobotulinumtoxinA treatment in the glabellar region at Baseline and Month 6
Galderma Study Site
Los Angeles, California, United States
Galderma Study Site
San Francisco, California, United States
Galderma Study Site
Santa Monica, California, United States
Galderma Study Site
Greenwood Village, Colorado, United States
Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines
Percentage of subjects satisfied with the treatment results assessed by satisfaction question at Month 12 visit.
Time frame: 12 months
Subject Satisfaction With Aesthetic Outcome in Treated Area
based on Subject Satisfaction questionnaire data
Time frame: Months 1,3,6,7,9 and 12
Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows
FACE-Q Appraisal of Lines: Between Eyebrows. Scored questionnaire to assess treatment outcome from subject's perspective. Minimum Rasch-transformed score = 0; Maximum Rasch-transformed score = 100. Higher score = better outcome.
Time frame: Months 1,3,6,7,9 and 12
Evaluate the Impact of Treatment; Psychological Function
FACE-Q Psychological Function. Scored questionnaire to assess treatment outcome from subject's perspective. Minimum Rasch-transformed score = 0; Maximum Rasch-transformed score = 100. Higher score = better outcome.
Time frame: Months 1,3,6,7,9 and 12
Subject Self-Assessment Using a 4-point Categorical Scale
Evaluate efficacy using a subject self-assessment scale that measures the severity of glabellar lines at maximum frown
Time frame: Months 1,3,6,7,9 and 12
Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity
Evaluate efficacy at visits using a 4-point photographic scale of glabellar line severity, by Investigator Live assessment at maximum frown.
Time frame: Months 1,3,6,7,9 and 12
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Galderma Study Site
Chicago, Illinois, United States
Galderma Study Site
Omaha, Nebraska, United States
Onset of Treatment Response
Subject perception of treatment response
Time frame: After treatment at Baseline and Month 6, assessed up to 1 week after each treatment visit