A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides

Phase 3

Completed

• Conditions: Forehead Rhytides; Glabellar Rhytides
• Interventions: Drug: Normal Saline; Biological: OnabotulinumtoxinA

• Registration Number: NCT02261467
• Lead Sponsor: Allergan

Brief Summary

This is a safety and efficacy study of onabotulinumtoxinA in subjects with forehead and glabellar facial rhytides (frown lines).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-03
• Study First Submitted QC: 2014-10-07
• Study First Posted: 2014-10-10
• Study Start: 2014-10-21
• Primary Completion: 2015-06-04
• Study Completion: 2016-04-26
• Disposition First Submitted: 2016-06-03
• Disposition First Submitted QC: 2016-06-03
• Disposition First Posted: 2016-06-07
• Results First Submitted: 2017-05-30
• Results First Submitted QC: 2017-05-30
• Results First Posted: 2017-06-23
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-18
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 421

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo followed by OnabotulinumtoxinA in Period 2	Normal Saline	Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.
OnabotulinumtoxinA	OnabotulinumtoxinA	OnabotulinumtoxinA 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 ≥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.
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 ≥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.
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.
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.

Trial Locations

Locations (16)

Laser & Skin Surgery Center of Indiana; 🇺🇸 Carmel, Indiana, United States

Sweat Clinics of Canada; 🇨🇦 Toronto, Ontario, Canada

Carruthers Dermatology Centre; 🇨🇦 Vancouver, British Columbia, Canada

Henry Ford Medical Center; 🇺🇸 West Bloomfield, Michigan, United States

Total Skin and Beauty Dermatology Center, PC; 🇺🇸 Birmingham, Alabama, United States

NW Dermatology and Research Center; 🇺🇸 Portland, Oregon, United States

Steven Fagien, MD, PA; 🇺🇸 Boca Raton, Florida, United States

About Skin Dermatology and DermSurgery, PC; 🇺🇸 Greenwood Village, Colorado, United States

Advanced Research Associates; 🇺🇸 Glendale, Arizona, United States

Clinical Science Institute; 🇺🇸 Santa Monica, California, United States

Coleman Center For Cosmetic Dermatologic Surgery; 🇺🇸 Metairie, Louisiana, United States

Dr. Shannon Humphrey, Inc.; 🇨🇦 Vancouver, British Columbia, Canada

Beacon Face and Dermatology Clinic; 🇮🇪 Dublin, Ireland

Arthur Swift Research, Inc.; 🇨🇦 Westmount, Quebec, Canada

Aesthetic Surgery Ireland; 🇮🇪 Dublin, Ireland

Jean Carruthers Cosmetic Dermatology; 🇨🇦 Vancouver, British Columbia, Canada