Clinical trial NCT02122536: Split-Face Prospective Study Comparing Botox to Xeomin for the Treatment of Facial Wrinkles
Official title: Split-Face, Double-blind, Single Center, Prospective Study Comparing OnabotulinumtoxinA to IncobotulinumtoxinA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Wrinkles
Lead sponsor: YMD Eye and Face
Sponsor class: OTHER
First posted: 2014-04-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Wrinkles Score
timeFrame: Preinjection assessment; assessment at 3 days, 2 weeks, 3 months, 4 months post-injection
Secondary outcomes:
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Center for Sight
state: Florida
Study officials:
affiliation: YMD Eye & Face
name: Ruth H Yeilding, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.