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

Phase 4

Completed

• Conditions: Glabellar Frown Lines
• Interventions: Drug: normal saline (placebo); Biological: botulinum toxin Type A

• Registration Number: NCT01391312
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-08
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-08
• Results First Submitted: 2012-08-24
• Results First Submitted QC: 2012-08-24
• Last Update Submitted: 2012-08-24
• Results First Posted: 2012-09-25
• Last Update Posted: 2012-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo (Normal Saline)	normal saline (placebo)	Normal Saline (placebo) injected into the glabellar region on Day 0.
botulinum toxin Type A	botulinum toxin Type A	Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30	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.
Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60	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.