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

Facial Wrinkles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122536
• Other study ID #: 318060-3
• Status: Completed
• Phase: N/A
• First received: October 30, 2013
• Last updated: April 22, 2014
• Start date: July 2012
• Est. completion date: November 2013

Study information

• Verified date: April 2014
• Source: YMD Eye and Face
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Facial Wrinkles

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Center for Sight	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
YMD Eye and Face

Country where clinical trial is conducted

United States, 

References & Publications (1)

Flynn TC, Carruthers A, Carruthers J, Geister TL, Görtelmeyer 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No