Patient Satisfaction Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Frown Lines

A Pilot Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Glabellar Lines - Establishing Patient Satisfaction

This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in glabellar rhytides (frown lines) using a new treatment satisfaction measure.

Study Overview

• Status: Completed
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Biological: botulinum toxin Type A; Drug: normal saline (placebo)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • East Chicago, Illinois, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Moderate to severe glabellar wrinkles (frown lines)

Exclusion Criteria:

• Previous treatment with botulinum toxin therapy of any serotype
• Facial non-ablative resurfacing laser or light treatment, microdermabrasion, or superficial peels within 3 months
• Any facial cosmetic procedure with medium depth to deep facial chemical peels (e.g., trichloroacetic acid and phenol), mid-facial or periorbital laser skin resurfacing or permanent make-up within 6 months
• Mid-facial or periorbital treatment with non-permanent soft tissue fillers
• Subjects planning a facial cosmetic procedure or visible scars
• Previous cosmetic surgery to the upper face(e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
• Diagnoses of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
• History of facial nerve palsy
• A planned extended absence during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: botulinum toxin Type A; Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.	Biological: botulinum toxin Type A; botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.; Other Names: BOTOX® Cosmetic, Vistabel®, Vistabax®
Placebo Comparator: placebo (Normal Saline); Normal Saline (placebo) injected into the glabellar region on Day 0.	Drug: normal saline (placebo); Normal saline (placebo) injected into the glabellar region on Day 0.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30	Subjects assessed the improvement of their glabellar lines (area between the eyebrows) by answering the question: Compared to before receiving the study treatment, How do you currently feel about the appearance of your glabellar lines? on a 7-point scale where 0=Very much improved, 1=Much improved, 2=Minimally improved, 3=No change, 4=Minimally worse, 5=Much worse, 6=Very much worse. Improvement was defined as responses: 0=Very much improved, 1=Much improved and 2=Minimally improved.	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30	The Investigator rated the subject's severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 30. Responders were defined as participants with a score of 0=None or 1=Mild.	Day 30
Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60	The Investigator rated the subject's severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 60. Responders were defined as participants with a score of 0=None or 1=Mild.	Day 60

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: July 8, 2011
• First Submitted That Met QC Criteria: July 11, 2011
• First Posted (Estimate): July 12, 2011

Study Record Updates

• Last Update Posted (Estimate): September 25, 2012
• Last Update Submitted That Met QC Criteria: August 24, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: GMA-BTXC-11-001