At a glance
ClinicalIndex Comparison RecordN/ACompleted· 175 enrolled
Drug / intervention
botulinum toxin Type A +1 morebiological
Likely dose
botulinum toxin Type A 30 Unitsfrom 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.
A Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Single Treatment Cycle Study of BOTOX® Cosmetic (Botulinum Toxin Type A) Purified Neurotoxin Complex in Subjects With Forehead and Glabellar Rhytides
In Brief
A clinical study evaluating botulinum toxin Type A and Normal Saline for Facial Rhytides and Glabellar Frown Lines. Completed, enrolled 175 participants across 1 site.
Detailed Summary
This study evaluated the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of forehead lines (facial rhytides) when also administered to frown lines (glabellar rhytides).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFacial Rhytides, Glabellar Frown Lines
CountriesCanada
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
First PostedJul 2011
Primary CompletionOct 2011
Study CompletionFeb 2012
TodayJul 2026
First PostedJul 12, 2011
Enrollment StartJun 1, 2011
Primary CompletionOct 18, 2011
Study CompletionFeb 28, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.0 years ago
Interventions
botulinum toxin Type Abiological
Botulinum toxin Type A (total dose 30 Units or 40 Units) injected into bilateral forehead and frown line areas on Day 1.
Normal Salinedrug
Normal Saline (placebo) injected into bilateral forehead and frown line areas on Day 1.