A Safety and Efficacy Study of OnabotulinumtoxinA in Upper Facial Rhytides

Facial Rhytides Clinical Trial

Official title:

Evaluation of the Safety and Efficacy of Treatment With BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for Subjects With Facial Rhytides (Forehead Lines, Glabellar Lines, Lateral Canthal Lines)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02261493
• Other study ID #: 191622-143
• Secondary ID: 2014-001815-38
• Status: Completed
• Phase: Phase 3
• First received: October 3, 2014
• Last updated: November 1, 2016
• Start date: October 2014
• Est. completion date: April 2016

Study information

• Verified date: November 2016
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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]).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 787
• Est. completion date: April 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Moderate to severe forehead lines, glabellar lines, and crow's feet 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Facial Rhytides
• Facies
• Glabellar Rhytides

Intervention

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

Drug:
• Normal Saline
Placebo (normal saline) injected into the protocol-specified areas on Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects with at Least a 2-Grade Improvement from Baseline in Forehead Line Severity at Maximum Eyebrow Elevation as Assessed by both the Investigator and Subject on the 4-Point Facial Wrinkle Scale (FWS)		Baseline, Day 30	No
Secondary	Duration of Drug Effect for Subjects Who Receive Clinical Benefit at Day 30 Using the 4-Point Facial Wrinkle Scale (FWS)		12 Months	No
Secondary	Percentage of Subjects with a Rating of None or Mild for Forehead Lines at Maximum Elevation on the 4-Point FWS Assessed by the Investigator		Day 30	No
Secondary	Percentage of Subjects Reporting Treatment Satisfaction on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ)		Day 60	No
Secondary	Percentage of Subjects with =20-Point Improvement from Baseline on the Impact Domain of the FLSQ		Baseline, Day 30	No
Secondary	Percentage of Subjects with a =3-Point Improvement from Baseline on Items 1, 4, and 5 of the 11-Point Facial Line Outcomes (FLO-11) Questionnaire©		Baseline, Day 30	No