Subject Satisfaction With AbobutulinumtoxinA Treatment

Study Overview
=================
Brief Summary
-----------------
An interventional Phase 4 study to assess subject satisfaction with abobotulinumtoxinA treatment.

Detailed Description
-----------------
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.

Official Title
-----------------
A Multicenter, Open-Label, Interventional Study to Evaluate Subject Satisfaction of AbobutulinumtoxinA Treatments in Moderate to Severe Glabellar Lines

Conditions
-----------------
Glabellar Frown Lines

Intervention / Treatment
-----------------
* Biological: AbobotulinumtoxinA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to Severe Glabellar Lines at Maximum Frown Understands study requirements and signs an informed consent Exclusion Criteria: Known allergy to any component of study product Pregnant or breast feeding or intending to get pregnant during the study Botulinum toxin treatment in the face within 9 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AbobotulinumtoxinA<br>Open-label | Biological: AbobotulinumtoxinA<br>* AbobotulinumtoxinA treatment in the glabellar region at Baseline and Month 6<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Satisfaction With Aesthetic Outcome in Treated Area | based on Subject Satisfaction questionnaire data | 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. | 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. | 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 | 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. | Months 1,3,6,7,9 and 12 | 
| Onset of Treatment Response | Subject perception of treatment response | After treatment at Baseline and Month 6, assessed up to 1 week after each treatment visit |