Clinical trial NCT02261467: A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides
Official title: Evaluation of the Safety and Efficacy of Treatment With BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for Subjects With Forehead and Glabellar Facial Rhytides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Forehead Rhytides
Glabellar Rhytides
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-10-10
Enrollment: 421
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 forehead and glabellar facial rhytides (frown lines).


Eligibility criteria: Inclusion Criteria:

* Moderate to severe forehead and glabellar 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: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center, PC
state: Alabama
city: Glendale
country: United States
facility: Advanced Research Associates
state: Arizona
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Greenwood Village
country: United States
facility: About Skin Dermatology and DermSurgery, PC
state: Colorado
city: Boca Raton
country: United States
facility: Steven Fagien, MD, PA
state: Florida
city: Carmel
country: United States
facility: Laser & Skin Surgery Center of Indiana
state: Indiana
city: Metairie
country: United States
facility: Coleman Center For Cosmetic Dermatologic Surgery
state: Louisiana
city: West Bloomfield
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: Portland
country: United States
facility: NW Dermatology and Research Center
state: Oregon
city: Vancouver
country: Canada
facility: Carruthers Dermatology Centre
state: British Columbia
city: Vancouver
country: Canada
facility: Dr. Shannon Humphrey, Inc.
state: British Columbia
city: Vancouver
country: Canada
facility: Jean Carruthers Cosmetic Dermatology
state: British Columbia
city: Toronto
country: Canada
facility: Sweat Clinics of Canada
state: Ontario
city: Westmount
country: Canada
facility: Arthur Swift Research, Inc.
state: Quebec
city: Dublin
country: Ireland
facility: Aesthetic Surgery Ireland
city: Dublin
country: Ireland
facility: Beacon Face and Dermatology Clinic
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: De Boulle K, Werschler WP, Gold MH, Bruce S, Sattler G, Ogilvie P, Street J, Larsen KE, Yushmanova I, Lei X, Lee E, Vitarella D, Mao C. Phase 3 Study of OnabotulinumtoxinA Distributed Between Frontalis, Glabellar Complex, and Lateral Canthal Areas for Treatment of Upper Facial Lines. Dermatol Surg. 2018 Nov;44(11):1437-1448. doi: 10.1097/DSS.0000000000001612.