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Patient Satisfaction With Treatment of BOTOX® Cosmetic for the Temporary Correction of Moderate to Severe Glabellar Lines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00856414
First received: March 4, 2009
Last updated: November 8, 2011
Last verified: November 2011
History of Changes
  Purpose

This study evaluates the patient satisfaction and onset of effect following treatment with botulinum toxin Type A in the treatment of glabellar rhytids (frown lines)


Condition Intervention Phase
Skin Aging
 Biological: botulinum toxin Type A
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Botox Skin Aging
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • The First Visit Onset of Efficacy as Measured by Physician Assessment [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    The first visit onset of efficacy as measured by physician assessment. Onset is determined by a yes/no answer to the question "Since injecting the patient, have you noticed any effect on the appearance of the patient's frown lines (lines between the eyebrows)?" at days 2, 3, 4, 7, and 14.

  • The First Visit Onset of Efficacy as Measured by Subject Assessment [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    The first visit onset of efficacy as measured by subject assessment. Onset is determined by a yes/no answer to the question "Since being injected, have you noticed any effect on the appearance of your frown lines (lines between the eyebrows)?" at days 2, 3, 4, 7, and 14.


Secondary Outcome Measures:
  • Average Subject Assessment Score in Improvement of Appearance of Frown Lines [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    Average subject assessment score in improvement of appearance of frown lines (lines between the eyebrows) as measured by a 7-point scale (1=very much improved and 7=very much worse)on a daily basis. The average scores over the 1st diary week (1-7 days) and the 2nd diary week (8-14 days) are presented.

  • Change From Baseline in Patient Satisfaction as Measured by Facial Line Outcome (FLO) Questionnaire Score [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]
    Change from baseline in patient satisfaction as measured by FLO questionnaire comprised of 11 items that assess subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on a 11-point scale (0=not at all, 5=somewhat, 10=very much) and the sums are converted to the total FLO score. The minimum total FLO score is 0 (worst) and the maximum total FLO score is 100 (best). The total FLO score was calculated at baseline and Day 14. A positive number change from baseline indicates an improvement.

  • Percentage of Patients Reporting Self-Perception of Age (SPA) [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]
    Percentage of patients reporting their SPA. SPA is measured by a questionnaire. Patients were asked to compare their facial appearance to their current age. Response options were "Looking younger", "Looking current age", and "Looking older". Results for each response are presented for Baseline and Day 14.


Enrollment: 45
Study Start Date: March 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
botulinum toxin Type A 20U
 Biological: botulinum toxin Type A
20U, up to two injections administered intramuscularly into the glabella (2 in each side of the corrugators and 1 in the procerus)
Other Name: BOTOX®

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female subjects of any race, 35-55 years of age
  • Moderate to severe glabellar wrinkles (lines between the eyebrows)

Exclusion Criteria:

  • Previous botulinum toxin therapy
  • Subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
  • Subjects planning a facial cosmetic procedure or visible scars
  • Previous cosmetic surgery to the upper face
  • Medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function
  • History of facial nerve palsy
  • Allergy or sensitivity to any component of the study medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856414

Locations
United States, Florida
West Palm Beach, Florida, United States
United States, Michigan
Livonia, Michigan, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00856414     History of Changes
Other Study ID Numbers: MA-BTX-0806
Study First Received: March 4, 2009
Results First Received: September 22, 2011
Last Updated: November 8, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013