CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 787 enrolled
Drug / intervention
OnabotulinumtoxinA +1 morebiological
Likely dose
OnabotulinumtoxinA injected into protocol-specified facial areas; subjects receive at least 1 and up to 3 treatmentsAI-extracted
Key inclusion· 2
  • ✓Moderate to severe forehead lines, glabellar lines, and crow's feet lines
  • ✓Willing to have facial photos taken
Key exclusion· 8
  • ✕Prior exposure to any botulinum toxin serotype for any indication
  • ✕Anticipated need for botulinum toxin treatment during the study (other than study treatment)
  • ✕Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
  • ✕Facial resurfacing laser, light treatment, microdermabrasion, or superficial peels within 3 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02261493
NCT02261493Phase 3Completed
CompareCT.gov

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)

Allergan·interventional·Posted Oct 10, 2014·Updated Jul 25, 2017

In Brief

A Phase 3 clinical trial evaluating OnabotulinumtoxinA and Normal Saline for Facial Rhytides and Glabellar Rhytides. Completed, enrolled 787 participants across 24 sites in 4 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFacial Rhytides, Glabellar Rhytides
CountriesBelgium, Germany, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 10, 2014
Enrollment StartOct 27, 2014
Primary CompletionJun 3, 2015
Study CompletionApr 20, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.7 years ago

Interventions

OnabotulinumtoxinAbiological

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

Normal Salinedrug

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