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

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.

Study Overview

• Status: Completed
• Conditions: Facial Wrinkles
• Intervention / 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; 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

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Sarasota, Florida, United States, 34239
      • Center for Sight

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Xeomin right side; Xeomin to left side of face; Patients were randomized as to which side of the face was treated with Xeomin.	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.; Other Names: incobotulinumtoxinA (Xeomin)
ACTIVE_COMPARATOR: Botox right side; Botox to left side; Patients were randomized as to which side of the face was treated with Botox.	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; Other Names: onabotulinumtoxinA (Botox)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Wrinkles Score	Objective assessment of change in wrinkles score pre and post injection of the crow's feet, glabella, and forehead using the "Validated Assessment Scaled for the Upper Face" published by Flynn et al. 2012. At the end of the study the delta wrinkle score from pre-injection to each followup assessment for each area will be calculated.	Preinjection assessment; assessment at 3 days, 2 weeks, 3 months, 4 months post-injection

Collaborators and Investigators

• Sponsor: YMD Eye and Face
• Investigators: Principal Investigator: Ruth H Yeilding, MD, YMD Eye & Face

Publications and helpful links

General Publications

• Flynn TC, Carruthers A, Carruthers J, Geister TL, Gortelmeyer R, Hardas B, Himmrich S, Kerscher M, de Maio M, Mohrmann C, Narins RS, Pooth R, Rzany B, Sattler G, Buchner L, Benter U, Fey C, Jones D. Validated assessment scales for the upper face. Dermatol Surg. 2012 Feb;38(2 Spec No.):309-19. doi: 10.1111/j.1524-4725.2011.02248.x.
• Yeilding RH, Fezza JP. A Prospective, Split-Face, Randomized, Double-Blind Study Comparing OnabotulinumtoxinA to IncobotulinumtoxinA for Upper Face Wrinkles. Plast Reconstr Surg. 2015 May;135(5):1328-1335. doi: 10.1097/PRS.0000000000001255.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): November 1, 2012
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: October 30, 2013
• First Submitted That Met QC Criteria: April 22, 2014
• First Posted (ESTIMATE): April 24, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): April 24, 2014
• Last Update Submitted That Met QC Criteria: April 22, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
• Other Study ID Numbers: 318060-3