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

YMD Eye and Face

Status: Completed

Conditions: Facial Wrinkles

Treatments: Drug: Xeomin to right side of face in half of the subjects; Xeomin to left side of face in the other half of subjects; 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

Study type: Interventional

Funder types: Other

Identifiers

NCT02122536

318060-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• males and females age 18 or older.

Exclusion criteria

• Previous treatment with a neuromodulator in the last 6 months
• previous brow lift
• currently pregnant or breastfeeding
• a history of neurological disease or deficit
• an active facial skin infection
• an allergy to neuromodulators

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 2 patient groups

Xeomin right side; Xeomin to left side of face

Active Comparator group

Description:

Patients were randomized as to which side of the face was treated with Xeomin.

Treatment:

Drug: Xeomin to right side of face in half of the subjects; Xeomin to left side of face in the other half of subjects

Botox right side; Botox to left side

Active Comparator group

Description:

Patients were randomized as to which side of the face was treated with Botox.

Treatment:

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