Brow Lifting With Dysport
The purpose of this study is to provide data to assess Dysport™ injections as a treatment therapy for brow ptosis. This study will assess the outcome of brow lifting with use of Dysport.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Brow Lifting With Dysport|
- Correction of brow ptosis with dysport injection [ Time Frame: 6 Months ] [ Designated as safety issue: No ]Subjects will be assessed using 5-point brow positioning grading scale at baseline, day 14, month 1,2,4 and 6 months.
|Study Start Date:||September 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Dysport injections into the glabella and orbicularis oculi muscles with dose based on muscle mass.
Patients entering will be based on gender and assessment of the glabella region (including the corrugators, procerus, and medial frontalis muscles). Muscle mass will be graded separately for males and females as +, ++, or+++ (light/small, moderate/medium, or heavy/large). Male patients will receive 0.3 mL to 0.4 mL (60, 70, or 80 units) in five equally divided doses of Dysport™ and female patients will receive 0.25 mL to 0.35 mL (50, 60 or 70 units) in equally divided doses of Dysport™ at 5 designated injection sites in the glabellar region. On (Day0) patients will be treated with Dysport™ 10 to 20 units bilaterally to the depressor component of the orbicularis. The dosing for patients will be based on assessment of orbicularis muscle mass. Patients will receive .05 mL to 0.1 mL (10 or 20 units) in two equally divided doses of Dysport™. Muscle mass will not be graded based upon gender for this region.
One of the most common reasons that patients present to both dermatologists and plastic surgeons is for brow and lid ptosis. Although some patients that present for these entities require surgery, most will decline to have surgical intervention. Alternative treatments include brow lifting with botulinum toxins.
Brow lifting with botulinum toxins may be performed by injecting the muscles responsible for brow and lid depression. These muscles include: the corrugators, procerus, medical aspect of the frontalis and the depressor component of the orbicularis oculi muscles. By relaxing these muscles, the brow elevators may be able to lift the brow and help both brow and lid ptosis. This trial is unique as it utilizes Dysport to treat an entire anatomic muscle group (the brow depressors) rather than injecting isolated muscles._
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401803
|United States, Florida|
|Kenneth R. Beer, M.D., PA|
|West Palm Beach, Florida, United States, 33401|
|Principal Investigator:||Kenneth Beer, M.D.||Kenneth Beer, M.D.,PA|