Skip to main content
OpenTrials
Completed

NCT Number: NCT00856414

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

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Skin Aging

Age range

35 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

West Palm Beach, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Botulinum toxin type A

Biological

20U, up to two injections administered intramuscularly into the glabella (2 in each side of the corrugators and 1 in the procerus)

Other names: BOTOX®

Primary outcomes

  1. The First Visit Onset of Efficacy as Measured by Physician Assessment

    Time frame: 14 Days

    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.

  2. The First Visit Onset of Efficacy as Measured by Subject Assessment

    Time frame: 14 Days

    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 outcomes

  1. Average Subject Assessment Score in Improvement of Appearance of Frown Lines

    Time frame: 14 Days

    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.

  2. Change From Baseline in Patient Satisfaction as Measured by Facial Line Outcome (FLO) Questionnaire Score

    Time frame: Baseline, Day 14

    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.

  3. Percentage of Patients Reporting Self-Perception of Age (SPA)

    Time frame: Baseline, Day 14

    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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 5, 2009
Registry last updated
Jan 29, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.