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

Glabellar Frown Lines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391312
• Other study ID #: GMA-BTXC-11-001
• Status: Completed
• Phase: Phase 4
• First received: July 8, 2011
• Last updated: August 24, 2012
• Start date: June 2011
• Est. completion date: October 2011

Study information

• Verified date: August 2012
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glabellar Frown Lines

Intervention

Biological:
• botulinum toxin Type A
botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.

Drug:
• normal saline (placebo)
Normal saline (placebo) injected into the glabellar region on Day 0.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No