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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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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

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Facial Wrinkles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Xeomin right side; Xeomin to left side of face

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Subjects were randomized to which side of the face would be treated with Xeomin.

Botox right side; Botox to left side

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Subjects were randomized to which side of the upper face would be treated with Botox

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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incobotulinumtoxinA (Xeomin) onabotulinumtoxinA (Botox)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes