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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01391312
First received: July 8, 2011
Last updated: August 24, 2012
Last verified: August 2012
History of Changes

July 8, 2011
August 24, 2012
June 2011
October 2011   (final data collection date for primary outcome measure)
Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30 [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
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.
Subject Global Assessment of Change (SGA) [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01391312 on ClinicalTrials.gov Archive Site
  • Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30 [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 60 ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Glabellar Frown Lines
  • Biological: botulinum toxin Type A
    botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
    Other Name: BOTOX® Cosmetic, Vistabel®, Vistabax®
  • Drug: normal saline (placebo)
    Normal saline (placebo) injected into the glabellar region on Day 0.
  • Active Comparator: botulinum toxin Type A
    Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
    Intervention: Biological: botulinum toxin Type A
  • Placebo Comparator: placebo (Normal Saline)
    Normal Saline (placebo) injected into the glabellar region on Day 0.
    Intervention: Drug: normal saline (placebo)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01391312
GMA-BTXC-11-001
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP