At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 176 enrolled
Drug / intervention
Botulinum toxin type A +2 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.
A Phase II, Double Blind, Randomised, Placebo and Active Comparator Controlled Study to Assess the Safety and Efficacy of Three Doses of Dysport RU (20 U, 50 U, and 75 U) Administered as a Single Treatment Cycle to Improve the Appearance of Moderate to Severe Glabellar Lines
In Brief
A Phase 2 clinical trial evaluating Botulinum toxin type A and Placebo for Glabellar Frown Lines. Completed, enrolled 176 participants across 8 sites in 2 countries.
Detailed Summary
The primary objective is to assess the dose response versus placebo of a single treatment of Dysport RU (Dysport RU, Ready to Use, for injection), for the improvement in appearance of moderate to severe glabellar lines at maximum frown.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlabellar Frown Lines
CountriesFrance, Germany
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2011
First PostedApr 2011
Primary CompletionSep 2011
TodayJul 2026
First PostedApr 12, 2011
Enrollment StartMar 1, 2011
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.2 years ago
Interventions
Botulinum toxin type Abiological
I.M. (in the muscle) injection on day 1 (single treatment cycle)
Botulinum toxin type Abiological
I.M. on day 1 (single treatment cycle)
Placebodrug
I.M. on day 1 (single treatment cycle)