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Completed

NCT Number: NCT01391312

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

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

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Key information

Conditions

Glabellar Frown Lines

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

East Chicago, Illinois, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin type A

Biological

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

Other names: BOTOX® Cosmetic, Vistabel®, Vistabax®

Normal saline (placebo)

Drug

Normal saline (placebo) injected into the glabellar region on Day 0.

Primary outcomes

  1. Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30

    Time frame: 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 outcomes

  1. Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30

    Time frame: 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.

  2. Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 12, 2011
Registry last updated
Sep 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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