Clinical trial NCT02261493: A Safety and Efficacy Study of OnabotulinumtoxinA in Upper Facial Rhytides
Official title: Evaluation of the Safety and Efficacy of Treatment With BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for Subjects With Facial Rhytides (Forehead Lines, Glabellar Lines, Lateral Canthal Lines)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Facial Rhytides
Glabellar Rhytides
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-10-10
Enrollment: 787
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a safety and efficacy study of onabotulinumtoxinA in subjects with upper facial rhytides (forehead lines, glabellar lines, lateral canthal lines \[crow's feet lines\]).


Eligibility criteria: Inclusion Criteria:

* Moderate to severe forehead lines, glabellar lines, and crow's feet lines
* Willing to have facial photos taken

Exclusion Criteria:

* Prior exposure to botulinum toxin of any serotype for any indication
* Anticipated need for treatment with botulinum toxin of any serotype for any indication during the study, other than study treatment
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
* Any facial resurfacing laser or light treatment, microdermabrasion, or superficial peels in the past 3 months
* Any medium depth or deep depth facial chemical peels; facial skin resurfacing; or permanent facial make-up in the past 6 months
* Any nonpermanent soft tissue fillers, or treatment with oral retinoids in the past year - Prior face lift, thread lift, eyebrow lift, or related procedures (eg, eyelid and/or eyebrow surgery)
* Prior facial treatment with permanent soft tissue fillers, synthetic implants (eg, Gore-Tex®), and/or fat transplantation

Primary outcomes:
measure: Percentage of Subjects With ≥2-Grade Improvement From Baseline on Both the Investigator's and Subject's Facial Wrinkle Scale (FWS) Ratings of Forehead Line Severity at Maximum Eyebrow Elevation
timeFrame: Baseline, Day 30
Secondary outcomes:
measure: Percentage of Subjects With an Investigator Rating of None or Mild on the 4-Grade FWS for Forehead Line Severity at Maximum Eyebrow Elevation
timeFrame: Day 30
measure: Percentage of Subjects With ≥1-Grade Improvement From Baseline on the Investigator's FWS Rating of Forehead Line Severity at Rest
timeFrame: Baseline, Day 30
measure: Percentage of Subjects Reporting Mostly Satisfied or Very Satisfied on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ) Item 5
timeFrame: Day 60
measure: Percentage of Subjects With ≥20-Point Improvement From Baseline on the Impact Domain of the FLSQ Among Subjects With Baseline Score ≥ 20 Points
timeFrame: Baseline, Day 30
measure: Percentage of Subjects With a ≥3-Point Improvement From Baseline on Item 4 of the 11-Point Facial Line Outcomes (FLO-11) Questionnaire©
timeFrame: Baseline, Day 30
measure: Time to Retreatment Eligibility
timeFrame: 12 Months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: The Petrus Center for Aesthetic
state: Arkansas
city: Los Angeles
country: United States
facility: Westside Aesthetics
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Newport Beach
country: United States
facility: Steve Yoelin, MD Medical Associates, Inc.
state: California
city: Miami
country: United States
facility: Baumann Cosmetic & Research Institute
state: Florida
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Mount Kisco
country: United States
facility: The Center For Dermatology Cosmetic and Laser Surgery
state: New York
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Houston
country: United States
facility: The Center for Skin Research
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Aalst
country: Belgium
facility: Aalst Dermatology Clinic
city: Jette
country: Belgium
facility: UZ Brussel
city: Limburg
country: Belgium
facility: Medical Skin Care - Sint-Truiden
city: Darmstadt
country: Germany
facility: Rosenpark Research
city: Köln Nordrhein-Westfalen
country: Germany
facility: Hautzentrum Koeln (Cologne Dermatology)
city: München
country: Germany
facility: Hautok und hautok-cosmetics
city: München
country: Germany
facility: Praxisgemeinschaft Theatiner46
city: Starnberg
country: Germany
facility: Hautzentrum am Starnberger See GmbH
city: Wuppertal
country: Germany
facility: CentroDerm Study Center
city: Basingstoke
country: United Kingdom
facility: Shakespeare House Health Centre, General Practice
city: Birmingham
country: United Kingdom
facility: Medizen Clinic
city: Chichester
country: United Kingdom
facility: The Bosham Clinic
city: Coatbridge
country: United Kingdom
facility: Waverlery Medical Practice
city: Whitegate
country: United Kingdom
facility: The Gatehouse
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: