Patient Satisfaction With Treatment of BOTOX® Cosmetic for the Temporary Correction of Moderate to Severe Glabellar Lines
This study has been completed.
Information provided by (Responsible Party):
First received: March 4, 2009
Last updated: November 8, 2011
Last verified: November 2011
This study evaluates the patient satisfaction and onset of effect following treatment with botulinum toxin Type A in the treatment of glabellar rhytids (frown lines)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Allergan:
Primary Outcome Measures:
- The First Visit Onset of Efficacy as Measured by Physician Assessment [ Time Frame: 14 Days ] [ Designated as safety issue: No ]The first visit onset of efficacy as measured by physician assessment. Onset is determined by a yes/no answer to the question "Since injecting the patient, have you noticed any effect on the appearance of the patient's frown lines (lines between the eyebrows)?" at days 2, 3, 4, 7, and 14.
- The First Visit Onset of Efficacy as Measured by Subject Assessment [ Time Frame: 14 Days ] [ Designated as safety issue: No ]The first visit onset of efficacy as measured by subject assessment. Onset is determined by a yes/no answer to the question "Since being injected, have you noticed any effect on the appearance of your frown lines (lines between the eyebrows)?" at days 2, 3, 4, 7, and 14.
Secondary Outcome Measures:
- Average Subject Assessment Score in Improvement of Appearance of Frown Lines [ Time Frame: 14 Days ] [ Designated as safety issue: No ]Average subject assessment score in improvement of appearance of frown lines (lines between the eyebrows) as measured by a 7-point scale (1=very much improved and 7=very much worse)on a daily basis. The average scores over the 1st diary week (1-7 days) and the 2nd diary week (8-14 days) are presented.
- Change From Baseline in Patient Satisfaction as Measured by Facial Line Outcome (FLO) Questionnaire Score [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]Change from baseline in patient satisfaction as measured by FLO questionnaire comprised of 11 items that assess subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on a 11-point scale (0=not at all, 5=somewhat, 10=very much) and the sums are converted to the total FLO score. The minimum total FLO score is 0 (worst) and the maximum total FLO score is 100 (best). The total FLO score was calculated at baseline and Day 14. A positive number change from baseline indicates an improvement.
- Percentage of Patients Reporting Self-Perception of Age (SPA) [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]Percentage of patients reporting their SPA. SPA is measured by a questionnaire. Patients were asked to compare their facial appearance to their current age. Response options were "Looking younger", "Looking current age", and "Looking older". Results for each response are presented for Baseline and Day 14.
|Study Start Date:||March 2009|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
botulinum toxin Type A 20U
Biological: botulinum toxin Type A
20U, up to two injections administered intramuscularly into the glabella (2 in each side of the corrugators and 1 in the procerus)
Other Name: BOTOX®
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