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

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ClinicalTrials.gov Identifier: NCT01391312
Recruitment Status : Completed
First Posted : July 12, 2011
Results First Posted : September 25, 2012
Last Update Posted : September 25, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Glabellar Frown Lines Biological: botulinum toxin Type A Drug: normal saline (placebo) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Glabellar Lines - Establishing Patient Satisfaction
Study Start Date : June 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Cosmetics

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 Name: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391312


Locations
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United States, Illinois
East Chicago, Illinois, United States
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01391312     History of Changes
Other Study ID Numbers: GMA-BTXC-11-001
First Posted: July 12, 2011    Key Record Dates
Results First Posted: September 25, 2012
Last Update Posted: September 25, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
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abobotulinumtoxinA
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents