A Safety and Efficacy Study of OnabotulinumtoxinA in Upper Facial Rhytides
- Conditions
- Facial RhytidesGlabellar Rhytides
- Interventions
- Drug: Normal SalineBiological: OnabotulinumtoxinA
- Registration Number
- NCT02261493
- Lead Sponsor
- Allergan
- Brief Summary
This is a safety and efficacy study of onabotulinumtoxinA in subjects with upper facial rhytides (forehead lines, glabellar lines, lateral canthal lines \[crow's feet lines\]).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 787
- Moderate to severe forehead lines, glabellar lines, and crow's feet lines
- Willing to have facial photos taken
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo followed by OnabotulinumtoxinA Dose A Normal Saline Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas. OnabotulinumtoxinA Dose A OnabotulinumtoxinA OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments. OnabotulinumtoxinA Dose B OnabotulinumtoxinA OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
- Primary Outcome Measures
Name Time Method 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 Baseline, Day 30 The Investigator and subject each assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 2-grade improvement from baseline assessed by both the Investigator and the subject are reported.
- Secondary Outcome Measures
Name Time Method Percentage of Subjects With a ≥3-Point Improvement From Baseline on Item 4 of the 11-Point Facial Line Outcomes (FLO-11) Questionnaire© Baseline, Day 30 The FLO-11 assess the subject's psychological and appearance-related impacts associated with facial lines. Item 4 is "I look older than my actual age because of my facial lines" with a range of possible scores from 0 = not at all to 10 = very much. Only subjects with baseline scores ≥ 3 are included in the analysis.
Percentage of Subjects With an Investigator Rating of None or Mild on the 4-Grade FWS for Forehead Line Severity at Maximum Eyebrow Elevation Day 30 The Investigator assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with a score of "none" and "mild" are reported.
Percentage of Subjects With ≥1-Grade Improvement From Baseline on the Investigator's FWS Rating of Forehead Line Severity at Rest Baseline, Day 30 The Investigator assessed the severity of the subject's forehead lines at rest using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 1-grade improvement assessed by the Investigator are reported.
Time to Retreatment Eligibility 12 Months Time to retreatment eligibility is defined as the number of days from treatment cycle 1 injection to the return to an Investigator FWS rating of moderate or severe at maximum eyebrow elevation. The FWS is a 4-grade scale, where 0=none, 1=mild, 2=moderate, and 3=severe. Only subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation on Day 30 are included in the analysis.
Percentage of Subjects Reporting Mostly Satisfied or Very Satisfied on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ) Item 5 Day 60 The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. Item 5 on the FLSQ asks "How satisfied are you with the effect your treatment had on your facial lines?" Responses included: very satisfied, mostly satisfied, neither satisfied or dissatisfied, mostly dissatisfied, or very dissatisfied. The percentage of subjects reporting a score of mostly satisfied or very satisfied with treatment are reported.
Percentage of Subjects With ≥20-Point Improvement From Baseline on the Impact Domain of the FLSQ Among Subjects With Baseline Score ≥ 20 Points Baseline, Day 30 The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. The Impact Domain measures the subject's appearance-related and emotional impacts of treatment and is composed of 5 questions with a possible range of scores from 0 (worst) to 100 (best), using a transformed scale. Only subjects with baseline scores ≥ 20 are included in the analysis.
Trial Locations
- Locations (24)
The Bosham Clinic
🇬🇧Chichester, United Kingdom
The Gatehouse
🇬🇧Whitegate, United Kingdom
Steve Yoelin, MD Medical Associates, Inc.
🇺🇸Newport Beach, California, United States
The Center for Skin Research
🇺🇸Houston, Texas, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Eye Research Foundation
🇺🇸Newport Beach, California, United States
Waverlery Medical Practice
🇬🇧Coatbridge, United Kingdom
The Center For Dermatology Cosmetic and Laser Surgery
🇺🇸Mount Kisco, New York, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States
Medical Skin Care - Sint-Truiden
🇧🇪Limburg, Belgium
Hautzentrum Koeln (Cologne Dermatology)
🇩🇪Köln Nordrhein-Westfalen, Germany
Praxisgemeinschaft Theatiner46
🇩🇪München, Germany
CentroDerm Study Center
🇩🇪Wuppertal, Germany
Shakespeare House Health Centre, General Practice
🇬🇧Basingstoke, United Kingdom
Medizen Clinic
🇬🇧Birmingham, United Kingdom
Baumann Cosmetic & Research Institute
🇺🇸Miami, Florida, United States
UZ Brussel
🇧🇪Jette, Belgium
Aalst Dermatology Clinic
🇧🇪Aalst, Belgium
Rosenpark Research
🇩🇪Darmstadt, Germany
The Petrus Center for Aesthetic
🇺🇸Little Rock, Arkansas, United States
Hautzentrum am Starnberger See GmbH
🇩🇪Starnberg, Germany
Hautok und hautok-cosmetics
🇩🇪München, Germany
Westside Aesthetics
🇺🇸Los Angeles, California, United States
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States