Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Forehead and Frown Lines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01391299
First received: July 8, 2011
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

This study evaluated the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of forehead lines (facial rhytides) when also administered to frown lines (glabellar rhytides).


Condition Intervention
Facial Rhytides
Glabellar Frown Lines
Biological: botulinum toxin Type A
Drug: Normal Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Single Treatment Cycle Study of BOTOX® Cosmetic (Botulinum Toxin Type A) Purified Neurotoxin Complex in Subjects With Forehead and Glabellar Rhytides

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Participants Achieving a Score of None or Mild by Investigator-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    The Investigator assessed the severity of the patient's forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30.

  • Percentage of Participants Achieving a Score of None or Mild by Subject-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    The patient assessed the severity of their forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30.


Secondary Outcome Measures:
  • Percentage of Participants Achieving Satisfied or Very Satisfied by Subject Assessment of Satisfaction of Appearance of Forehead Lines [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    Participants rated their overall satisfaction with the appearance of the forehead line area using a 5-point scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied or 5=very satisfied. The percentage of participants with a rating of satisfied or very satisfied at Day 30.

  • Percentage of Participants With a ≥1 Grade Improvement From Baseline by Investigator-Assessed FWS in Forehead Lines at Rest [ Time Frame: Baseline, Day 30 ] [ Designated as safety issue: No ]
    The Investigator assessed the severity of the patient's forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline.

  • Percentage of Participants With a ≥1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at Rest [ Time Frame: Baseline, Day 30 ] [ Designated as safety issue: No ]
    Participants assessed the severity of their forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline.


Enrollment: 175
Study Start Date: June 2011
Study Completion Date: February 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: botulinum toxin Type A (40 Units)
Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Biological: botulinum toxin Type A
Botulinum toxin Type A (total dose 30 Units or 40 Units) injected into bilateral forehead and frown line areas on Day 1.
Other Name: BOTOX® Cosmetic
Active Comparator: botulinum toxin Type A (30 Units)
Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
Biological: botulinum toxin Type A
Botulinum toxin Type A (total dose 30 Units or 40 Units) injected into bilateral forehead and frown line areas on Day 1.
Other Name: BOTOX® Cosmetic
Placebo Comparator: placebo (Normal saline)
Placebo (Normal saline) injected into bilateral forehead and frown line areas on Day 1.
Drug: Normal Saline
Normal Saline (placebo) injected into bilateral forehead and frown line areas on Day 1.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe forehead lines

Exclusion Criteria:

  • Current or previous botulinum toxin treatment of any serotype within one year
  • Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
  • Prior facial cosmetic surgery (e.g. prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
  • Facial laser or light treatment, microdermabrasion, or superficial peels within 3 months
  • Oral retinoid therapy within one year
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391299

Locations
Canada, Ontario
Toronto, Ontario, Canada
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01391299     History of Changes
Other Study ID Numbers: GMA-BTXC-10-002
Study First Received: July 8, 2011
Results First Received: October 26, 2012
Last Updated: October 26, 2012
Health Authority: Canada: Health Canada

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 July 28, 2014