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

ClinicalTrials.gov processed this record on September 18, 2014