At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 421 enrolled
Drug / intervention
OnabotulinumtoxinA +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of the Safety and Efficacy of Treatment With BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for Subjects With Forehead and Glabellar Facial Rhytides
In Brief
A Phase 3 clinical trial evaluating OnabotulinumtoxinA and Normal Saline for Forehead Rhytides and Glabellar Rhytides. Completed, enrolled 421 participants across 16 sites in 3 countries.
Detailed Summary
This is a safety and efficacy study of onabotulinumtoxinA in subjects with forehead and glabellar facial rhytides (frown lines).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsForehead Rhytides, Glabellar Rhytides
CountriesCanada, Ireland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2014
Enrollment StartOct 2014
Primary CompletionJun 2015
Study CompletionApr 2016
TodayJul 2026
First PostedOct 10, 2014
Enrollment StartOct 21, 2014
Primary CompletionJun 4, 2015
Study CompletionApr 26, 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.