A Safety and Efficacy Study of OnabotulinumtoxinA in Upper Facial Rhytides

NCT02261493 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 191622-1432014-001815-38
• Study Type: interventional
• Target: 787
• Locations: 4 countries
• Sites: 24

Brief Summary

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

Conditions

Facial 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 (3)

OnabotulinumtoxinA Dose A

EXPERIMENTAL

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

Biological: OnabotulinumtoxinA

OnabotulinumtoxinA Dose B

EXPERIMENTAL

OnabotulinumtoxinA Dose B 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 Dose A

PLACEBO COMPARATOR

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.

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 Dose A; OnabotulinumtoxinA Dose B

Normal Saline DRUG

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

Placebo followed by OnabotulinumtoxinA Dose A

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 lines, glabellar lines, and crow's feet 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 (24)

The Petrus Center for Aesthetic

Little Rock, Arkansas, 72205, United States

Location

Westside Aesthetics

Los Angeles, California, 90025, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Steve Yoelin, MD Medical Associates, Inc.

Newport Beach, California, 92663, United States

Location

Baumann Cosmetic & Research Institute

Miami, Florida, 33137, United States

Location

Saint Louis University

St Louis, Missouri, 63122, United States

Location

The Center For Dermatology Cosmetic and Laser Surgery

Mount Kisco, New York, 10549, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

The Center for Skin Research

Houston, Texas, 77056, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

Aalst Dermatology Clinic

Aalst, Belgium

Location

UZ Brussel

Jette, Belgium

Location

Medical Skin Care - Sint-Truiden

Limbourg, Belgium

Location

Rosenpark Research

Darmstadt, Germany

Location

Hautzentrum Koeln (Cologne Dermatology)

Köln Nordrhein-Westfalen, Germany

Location

Hautok und hautok-cosmetics

München, Germany

Location

Praxisgemeinschaft Theatiner46

München, Germany

Location

Hautzentrum am Starnberger See GmbH

Starnberg, Germany

Location

CentroDerm Study Center

Wuppertal, Germany

Location

Shakespeare House Health Centre, General Practice

Basingstoke, RG24 9DT, United Kingdom

Location

Medizen Clinic

Birmingham, B74 2UG, United Kingdom

Location

The Bosham Clinic

Chichester, PO18 8AN, United Kingdom

Location

Waverlery Medical Practice

Coatbridge, ML5 3PA, United Kingdom

Location

The Gatehouse

Whitegate, CW9 8UW, United Kingdom

Location

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 27, 2014
• Primary Completion: June 3, 2015
• Study Completion: April 20, 2016
• Last Updated: July 25, 2017
• Results First Posted: July 25, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6); US (10); GB (5); BE (3)