Safety and Efficacy of Two Types of Botulinum Toxin Type A For the Treatment of Glabellar Lines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01271452
First received: January 5, 2011
Last updated: December 9, 2011
Last verified: December 2011
  Purpose

This study will evaluate the safety and efficacy of two different types of botulinum toxin type A for the treatment of glabellar frown lines.


Condition Intervention Phase
Glabellar Lines
Biological: botulinum toxin type A
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Number of Subjects With a Treatment Response at Day 28 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the Facial Wrinkle Scale (FWS) [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Number of subjects with a treatment response at Day 28 based on the injector's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.


Secondary Outcome Measures:
  • Number of Subjects With a Treatment Response at Day 84 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    Number of subjects with a treatment response at Day 84 based on the injector's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.

  • Number of Subjects With a Treatment Response at Day 98 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS [ Time Frame: Day 98 ] [ Designated as safety issue: No ]
    Number of subjects with a treatment response at Day 98 based on the injector's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.

  • Number of Subjects With a Treatment Response at Day 112 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS [ Time Frame: Day 112 ] [ Designated as safety issue: No ]
    Number of subjects with a treatment response at Day 112 based on the injector's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.

  • Number of Subjects With a Treatment Response at Day 28 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Number of subjects with a treatment response at Day 28 based on the subject's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.

  • Number of Subjects With a Treatment Response at Day 84 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    Number of subjects with a treatment response at Day 84 based on the subject's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.

  • Number of Subjects With a Treatment Response at Day 98 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS [ Time Frame: Day 98 ] [ Designated as safety issue: No ]
    Number of subjects with a treatment response at Day 98 based on the subject's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.

  • Number of Subjects With a Treatment Response at Day 112 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS [ Time Frame: Day 112 ] [ Designated as safety issue: No ]
    Number of subjects with a treatment response at Day 112 based on the subject's assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.


Enrollment: 224
Study Start Date: September 2010
Study Completion Date: April 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vistabel®
botulinum toxin type A (Vistabel®)
Biological: botulinum toxin type A
20 units (total dose) botulinum toxin type A injected into glabellar region on Day 0
Other Names:
  • Vistabel®
  • BOTOX® Cosmetic
Active Comparator: Bocouture®
botulinum toxin type A (Bocouture®)
Biological: botulinum toxin type A
30 units (total dose) botulinum toxin type A injected into glabellar region on Day 0
Other Name: Bocouture®

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe glabellar frown lines

Exclusion Criteria:

  • Diagnosis of myasthenia gravis or Eaton Lambert syndrome
  • Aesthetic treatment with botulinum toxin within 6 months or planned treatment with botulinum toxin for any reason during the study
  • Prior filler treatments, surgeries, insertion procedures in/to the glabellar region
  • Facial cosmetic procedures in the glabellar area within 6 months
  • Bleeding disorders or use of anticoagulants within 10 days
  • History of facial nerve palsy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271452

Locations
Germany
Munich, Bavaria, Germany
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01271452     History of Changes
Other Study ID Numbers: MAF/AGN/Facial/011, 2010-021401-20
Study First Received: January 5, 2011
Results First Received: December 9, 2011
Last Updated: December 9, 2011
Health Authority: Germany: Ministry of Health

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 16, 2014