At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 121 enrolled
Drug / intervention
Botulinum Toxin Abiological
Likely dose
Botulinum Toxin A 1 mlfrom 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.
Phase III Open Label Clinical Trial to Assess Efficacy, Safety and Tolerability of Botulinum Toxin A (Xeomin®) in Treatment of Expression Wrinkles in the Upper Third of the Face
In Brief
A Phase 3 clinical trial evaluating Botulinum Toxin A for Skin Aging. Completed, enrolled 121 participants across 1 site.
Detailed Summary
The purpose of this study is to determinate whether Xeomin® (Botulinum toxin Type A) is safe, effective and tolerable in woman aged 30 to 50 years old for treatment of mild, moderate or severe expression lines (wrinkles) in the upper third of the face. The main outcome was the change in appearance of the wrinkles two weeks (visit 3) after product application as compared with baseline assessment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSkin Aging
CountriesBrazil
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2009
First PostedSep 2009
Primary CompletionJun 2010
Study CompletionNov 2010
TodayJul 2026
First PostedSep 30, 2009
Enrollment StartSep 1, 2009
Primary CompletionJun 1, 2010
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 16.8 years ago
Interventions
Botulinum Toxin Abiological
100 U DL50 lyophilized powder for reconstitution in 1 ml Saline Solution 0.9%.