Safety and Efficacy of Two Types of Botulinum Toxin Type A For the Treatment of Glabellar Lines - Full Text View

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:

MedlinePlus related topics: Botox

Drug Information available for: OnabotulinumtoxinA

U.S. FDA Resources

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 May 21, 2013