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
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 April 17, 2014