Clinical trial NCT01271452: Safety and Efficacy of Two Types of Botulinum Toxin Type A For the Treatment of Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glabellar Lines
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-01-06
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: Day 28
Secondary outcomes:
measure: 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
timeFrame: Day 84
measure: 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
timeFrame: Day 98
measure: 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
timeFrame: Day 112
measure: 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
timeFrame: Day 28
measure: 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
timeFrame: Day 84
measure: 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
timeFrame: Day 98
measure: 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
timeFrame: Day 112
Other outcomes:
Locations:
city: Munich
country: Germany
state: Bavaria
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Moers-Carpi M, Dirschka T, Feller-Heppt G, Hilton S, Hoffmann K, Philipp-Dormston WG, Rutter A, Tan K, Chapman MA, Fulford-Smith A. A randomised, double-blind comparison of 20 units of onabotulinumtoxinA with 30 units of incobotulinumtoxinA for glabellar lines. J Cosmet Laser Ther. 2012 Dec;14(6):296-303. doi: 10.3109/14764172.2012.738913. Epub 2012 Nov 15.