NCT02122536

Split-Face Prospective Study Comparing Botox to Xeomin for the Treatment of Facial Wrinkles

Split-Face, Double-blind, Single Center, Prospective Study Comparing OnabotulinumtoxinA to IncobotulinumtoxinA

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: YMD Eye and Face · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of this prospective, randomized, double-blind, intraindividual split face study will be to compare onabotulinumtoxinA to incobotulinumtoxinA for the correction of facial wrinkles using a 1:1 dose ratio.

Detailed description

Patients will be randomized to which side of the face will be injected with onabotulinumtoxinA and incobotulinumtoxinA. A total dose of 22.5 units of onabotulinumtoxinA and 22.5 units of incobotulinumtoxinA will be administered at baseline to the respected side of the face. One vial (100 MU) of BoNTA will be reconstituted with 2.0 mL of 0.9% sterile saline solution. Similarly, one vial (100 MU) of BTXCo will be reconstituted with 2.0 mL of 0.9% sterile saline solution. 2.5 units of the respective neurotoxin will be administered to three sites in the crow's feet area on each side (7.5 units total for one side), 2.5 units to two locations of the forehead on each side (5 units total for one side), and 5.0 units to two locations in the glabella on each side(10 units total for one side). The duration of the study will be 4 months. The followup visits after the initial injections will be at 3 days, 2 weeks, 3 months, and 4 months after the initial treatment. At each of these visits, standardized digital photographs of the treated facial area will be taken. Both static and dynamic photos will be taken of each region. At the conclusion of the study, three independent raters will individually perform blind assessments of the photographs according to the Validated Assessment Scaled for the Upper Face published by Flynn et al 2012.

Conditions

• Facial Wrinkles

Interventions

Type	Name	Description
DRUG	Xeomin to right side of face in half of the subjects; Xeomin to left side of face in the other half of subjects	Subjects were randomized to which side of the face would be treated with Xeomin.
DRUG	Botox to right side of face in half of the subjects (randomized); Botox to the left side of the face in the other half of subjects	Subjects were randomized to which side of the upper face would be treated with Botox

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-11-01
• Completion: 2013-11-01
• First posted: 2014-04-24
• Last updated: 2014-04-24

Locations

1 site across 1 country: United States