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

NCT02122536 | Completed

• 1 other identifier: 318060-3
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Wrinkles

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Xeomin right side; Xeomin to left side of face

ACTIVE COMPARATOR

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

Botox right side; Botox to left side

ACTIVE COMPARATOR

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

Interventions

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

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

Also known as: incobotulinumtoxinA (Xeomin)

Xeomin right side; Xeomin to left side of face

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 DRUG

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

Also known as: onabotulinumtoxinA (Botox)

Botox right side; Botox to left side

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• males and females age 18 or older.

You may not qualify if:

• 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

Sponsors & Collaborators

• YMD Eye and Face: lead

Study Sites (1)

Center for Sight

Sarasota, Florida, 34239, United States

Location

Related Publications (2)

• 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.

  PMID: 22316187 BACKGROUND

• 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.

  PMID: 25919246 DERIVED

MeSH Terms

Interventions

incobotulinumtoxinA; Random Allocation; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Ruth H Yeilding, MD

  YMD Eye & Face

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: April 24, 2014
• Study Start: July 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2013
• Last Updated: April 24, 2014

Record last verified: 2014-04

Locations

US (1)