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

NCT02261467 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 191622-1422014-001860-36
• Study Type: interventional
• Target: 421
• Locations: 3 countries
• Sites: 16

Brief Summary

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

Conditions

Forehead Rhytides; Glabellar Rhytides

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Baseline, Day 30

Secondary Outcomes (6)

• 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

• Percentage of Subjects With ≥1-Grade Improvement From Baseline on the Investigator's FWS Rating of Forehead Line Severity at Rest

  Baseline, Day 30

• Percentage of Subjects Reporting Mostly Satisfied or Very Satisfied on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ) Item 5

  Day 60

• 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

• 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

Study Arms (2)

OnabotulinumtoxinA

EXPERIMENTAL

OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.

Biological: OnabotulinumtoxinA

Placebo followed by OnabotulinumtoxinA in Period 2

PLACEBO COMPARATOR

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.

Drug: Normal Saline

Interventions

OnabotulinumtoxinA BIOLOGICAL

OnabotulinumtoxinA injected into the protocol-specified areas. Subjects will receive at least 1 and up to 3 treatments.

Also known as: BOTOX® Cosmetic, botulinum toxin Type A

OnabotulinumtoxinA

Normal Saline DRUG

Placebo (normal saline) injected into the protocol-specified areas on Day 1.

Placebo followed by OnabotulinumtoxinA in Period 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe forehead and glabellar lines
• Willing to have facial photos taken

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (16)

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, 35205, United States

Location

Advanced Research Associates

Glendale, Arizona, 85308, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

About Skin Dermatology and DermSurgery, PC

Greenwood Village, Colorado, 80111, United States

Location

Steven Fagien, MD, PA

Boca Raton, Florida, 33431, United States

Location

Laser & Skin Surgery Center of Indiana

Carmel, Indiana, 46032, United States

Location

Coleman Center For Cosmetic Dermatologic Surgery

Metairie, Louisiana, 70006, United States

Location

Henry Ford Medical Center

West Bloomfield, Michigan, 48322, United States

Location

NW Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Carruthers Dermatology Centre

Vancouver, British Columbia, V5Z 4E1, Canada

Location

Dr. Shannon Humphrey, Inc.

Vancouver, British Columbia, V5Z 4E1, Canada

Location

Jean Carruthers Cosmetic Dermatology

Vancouver, British Columbia, V5Z 4E1, Canada

Location

Sweat Clinics of Canada

Toronto, Ontario, M5R 3N8, Canada

Location

Arthur Swift Research, Inc.

Westmount, Quebec, H3Z 1B7, Canada

Location

Aesthetic Surgery Ireland

Dublin, Ireland

Location

Beacon Face and Dermatology Clinic

Dublin, Ireland

Location

Related Publications (1)

• 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.

  PMID: 30096106 BACKGROUND

MeSH Terms

Interventions

Botulinum Toxins, Type A; Saline Solution

Intervention Hierarchy (Ancestors)

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; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Tanya Brandstetter
• Organization: Allergan, Inc

brandstetter_tanya@Allergan.com

714-246-2567

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 10, 2014
• Study Start: October 21, 2014
• Primary Completion: June 4, 2015
• Study Completion: April 26, 2016
• Last Updated: January 8, 2019
• Results First Posted: June 23, 2017

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

IE (2); US (9); CA (5)